Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-25 @ 2:16 AM
Study NCT ID:
NCT04034004
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Low Back Pain and Meditation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zeidanlaboratory@ucsd.edu', 'phone': '858-246-8342', 'title': 'Dr. Fadel Zeidan', 'organization': 'UC San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The most significant limitation was performing highly invasive pain and pharmacologic testing during the coronavirus pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were evaluated from informed consent to data completion. This was observed in each study participant for an average of 8 weeks (i.e., through study completion).', 'description': 'Adverse Event: any problematic medical occurrence in a subject during study participation. Adverse events were assessed in each study participant from the time of informed consent to study completion (on average of 8 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion', 'description': 'All participants were administered the straight leg raise test across all testing sessions. After their respective interventions, participants were administered the straight leg raise test during naloxone and saline infusion, respectively.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion', 'description': 'All participants were administered the straight leg raise test across all testing sessions. After their respective interventions, participants were administered the straight leg raise test during naloxone and saline infusion, respectively.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.\n\nMindfulness: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.\n\nMeditation: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.'}, {'id': 'OG001', 'title': 'Non Mindfulness Meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.\n\nMindfulness: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.\n\nMeditation: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.'}], 'classes': [{'title': 'baseline session: supine 1', 'categories': [{'measurements': [{'value': '3.60', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'baseline session: straight leg raise test 1', 'categories': [{'measurements': [{'value': '4.83', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '5.41', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'baseline session: supine 2', 'categories': [{'measurements': [{'value': '4.13', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'baseline session: straight leg raise test 2', 'categories': [{'measurements': [{'value': '5.15', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '5.78', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'saline session: supine 1', 'categories': [{'measurements': [{'value': '3.23', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'saline session: straight leg raise test 1', 'categories': [{'measurements': [{'value': '4.37', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'saline session: supine 2', 'categories': [{'measurements': [{'value': '3.90', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'saline session: straight leg raise 2', 'categories': [{'measurements': [{'value': '3.67', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '5.32', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'naloxone session: supine 1', 'categories': [{'measurements': [{'value': '3.30', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'naloxone session: straight leg raise 1', 'categories': [{'measurements': [{'value': '4.30', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '6.10', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'naloxone session: supine 2', 'categories': [{'measurements': [{'value': '3.73', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '5.18', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'naloxone session: straight leg raise 2', 'categories': [{'measurements': [{'value': '3.45', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '5.52', 'spread': '2.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.', 'description': 'Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Four sessions of mindfulness-based mental training'}, {'id': 'OG001', 'title': 'Non-mindfulness Meditation', 'description': 'Taught to take slow deep breaths across four mental training sessions.'}], 'classes': [{'title': 'Baseline PCS', 'categories': [{'measurements': [{'value': '18.57', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '20.83', 'spread': '12.85', 'groupId': 'OG001'}]}]}, {'title': 'Session 7 PCS', 'categories': [{'measurements': [{'value': '15.33', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '18.48', 'spread': '13.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.', 'description': "This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience. The total range is from 0 - 52.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Roland-Morris Disability Questionnaire (RMDQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Four sessions of mindfulness-based mental training'}, {'id': 'OG001', 'title': 'Non-mindfulness Meditation', 'description': 'Taught to take slow deep breaths across four mental training sessions.'}], 'classes': [{'title': 'baseline RMDQ', 'categories': [{'measurements': [{'value': '12.86', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '13.85', 'spread': '6.34', 'groupId': 'OG001'}]}]}, {'title': 'session 7 RMDQ', 'categories': [{'measurements': [{'value': '12.03', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '14.02', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.', 'description': 'The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Higher scores indicate greater disability. Total RMDQ scores are used before and after each intervention by group. The range of scores is from 0 - 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Four sessions of mindfulness-based mental training'}, {'id': 'OG001', 'title': 'Non-mindfulness Meditation', 'description': 'Taught to take slow deep breaths across four mental training sessions.'}], 'classes': [{'title': 'baseline BPI severity', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'session 7 BPI severity', 'categories': [{'measurements': [{'value': '3.94', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '5.15', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'baseline BPI interference', 'categories': [{'measurements': [{'value': '4.40', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'session 7 BPI interference', 'categories': [{'measurements': [{'value': '3.38', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '2.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.', 'description': 'Pain severity and interference: impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Higher scores indicate higher chronic pain. BPI severity and interference scales are used and collected before and after each intervention. Higher BPI severity indicate higher chronic pain severity. Higher BPI interference scores indicate higher chronic pain interference.The scoring scale for severity and interference range from 0 - 10, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SF-12 Health Survey (SF-12) Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Four sessions of mindfulness-based mental training'}, {'id': 'OG001', 'title': 'Non-mindfulness Meditation', 'description': 'Taught to take slow deep breaths across four mental training sessions.'}], 'classes': [{'title': 'baseline SF physical functioning', 'categories': [{'measurements': [{'value': '52.50', 'spread': '28.88', 'groupId': 'OG000'}, {'value': '49.17', 'spread': '29.71', 'groupId': 'OG001'}]}]}, {'title': 'session 7 SF physical functioning', 'categories': [{'measurements': [{'value': '39.66', 'spread': '33.08', 'groupId': 'OG000'}, {'value': '44.83', 'spread': '33.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.', 'description': 'This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Meditation', 'description': 'Four sessions of mindfulness-based mental training'}, {'id': 'OG001', 'title': 'Non-mindfulness Meditation', 'description': 'Taught to take slow deep breaths across four mental training sessions.'}], 'classes': [{'title': 'intervention 1 effectiveness', 'categories': [{'measurements': [{'value': '4.83', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'intervention 2 effectiveness', 'categories': [{'measurements': [{'value': '4.05', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'intervention 3 effectiveness', 'categories': [{'measurements': [{'value': '4.21', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'intervention 4 effectiveness', 'categories': [{'measurements': [{'value': '4.51', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '5.40', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Delivered after completion of each of the 4 meditation intervention sessions. Up to 8 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Meditation and Saline First', 'description': 'After providing informed consent, 18 participants completed baseline testing.\n\nParticipants then completed a four session mindfulness meditation intervention where participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. One participant dropped out after the first intervention session.\n\nAfter their respective intervention, these participants received IV saline in session 6. Two participants were dismissed because of trouble administering the IV.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.\n\nAfter a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.'}, {'id': 'FG001', 'title': 'Non Mindfulness Meditation and Saline First', 'description': 'After providing informed consent, 18 participants completed baseline testing. 2 participants withdrew from this session\n\nParticipants then completed a four session non-mindfulness meditation intervention where participants were taught to independently practice closing their eyes and take a deep breath every few minutes.\n\nAfter their respective intervention, these participants received IV saline in session 6. One participants was dismissed because of trouble administering the IV.\n\nAfter a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7.'}, {'id': 'FG002', 'title': 'Mindfulness Meditation and Naloxone First', 'description': 'After providing informed consent, 17 participants participated in baseline testing. Two participants withdrew for scheduling issues after baseline.\n\nFifteen participants then completed a four session mindfulness meditation intervention where they were taught to focus on the changing sensations of the breath non-reactively\n\nAfter their respective intervention, these 15 participants received IV naloxone in session 6\n\nAfter a two day washout period, 15 participants returned to the clinic and performed the saline infusion in session 7.'}, {'id': 'FG003', 'title': 'Non Mindfulness Meditation and Naloxone First', 'description': 'After providing informed consent, 18 participants participated in baseline testing. Three participants withdrew for scheduling issues after baseline.\n\nFifteen participants then completed a four session non mindfulness meditation intervention where they were taught to independently take deep breaths.\n\nAfter their respective intervention, these participants received IV naloxone in session 6. However, a study nurse unintentionally instructed a patient that naloxone was to be infused and thus the participant was dismissed.\n\nAfter a two day washout period, 14 participants returned to the clinic and performed the saline infusion in session 7.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'could not find vein to administer IV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'nurse accidentally unblinded subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '500 individuals were screened for eligibility through the UCSD Recruitment services and study flyers. Enrollment started in January 2021 and data collection was completed in December of 2022.', 'preAssignmentDetails': '88 out of the 500 individuals were enrolled and participated in the baseline session. Seventeen out of the 88 were not randomized for the following reasons: Not responsive to straight leg raise test (n = 4), Intolerance to pain procedures (n = 3), Withdrew (n = 3), Scheduling issues (n = 1), Transportation issues (n = 1), Positive opioid test (n = 1), Inappropriate behavior (n = 1), Other pain management (n = 1), instruction incomprehension (n = 1) and Mindfulness experience (n = 1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.\n\nMindfulness: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.\n\nMeditation: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.'}, {'id': 'BG001', 'title': 'Non-mindfulness Meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.\n\nMindfulness: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.\n\nNaloxone: A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.\n\nSaline: A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.\n\nMeditation: A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'age', 'categories': [{'measurements': [{'value': '45', 'spread': '12', 'groupId': 'BG000'}, {'value': '47', 'spread': '13', 'groupId': 'BG001'}, {'value': '46', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Numerical pain ratings', 'classes': [{'title': 'straight leg raise test', 'categories': [{'measurements': [{'value': '4.83', 'spread': '2.21', 'groupId': 'BG000'}, {'value': '5.41', 'spread': '2.46', 'groupId': 'BG001'}, {'value': '5.12', 'spread': '2.34', 'groupId': 'BG002'}]}]}, {'title': 'supine', 'categories': [{'measurements': [{'value': '3.60', 'spread': '2.08', 'groupId': 'BG000'}, {'value': '4.69', 'spread': '2.25', 'groupId': 'BG001'}, {'value': '4.14', 'spread': '2.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Straight leg raise test induced numerical pain ratings were assessed using an 11-point scale where the minimum rating ("0") was designated as "no pain sensation" and the maximum ("10") as "most intense pain imaginable".\n\nPain ratings were collected while patients were lying on backs and in response to the straight leg raise test (SLR).\n\nThe following ratings correspond to the first SLR in the baseline session. Higher numerical ratings equated to higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The analysis population was not different from the assignment in participant flow.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-02', 'size': 230632, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-02T11:23', 'hasProtocol': True}, {'date': '2023-05-03', 'size': 30974, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-02T11:34', 'hasProtocol': False}, {'date': '2019-11-26', 'size': 166422, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-05T11:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the study physician, research coordinator, and research pharmacist will be aware of drug assignments. Research staff (nurses; research technicians) and the PI will be blinded to drug assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2019-05-09', 'resultsFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-02', 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SF-12 Health Survey (SF-12) Physical Functioning', 'timeFrame': 'Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.', 'description': 'This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning.'}], 'primaryOutcomes': [{'measure': 'Pain Ratings', 'timeFrame': 'Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.', 'description': 'Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.', 'description': "This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience. The total range is from 0 - 52."}, {'measure': 'The Roland-Morris Disability Questionnaire (RMDQ)', 'timeFrame': 'The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.', 'description': 'The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Higher scores indicate greater disability. Total RMDQ scores are used before and after each intervention by group. The range of scores is from 0 - 24.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.', 'description': 'Pain severity and interference: impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Higher scores indicate higher chronic pain. BPI severity and interference scales are used and collected before and after each intervention. Higher BPI severity indicate higher chronic pain severity. Higher BPI interference scores indicate higher chronic pain interference.The scoring scale for severity and interference range from 0 - 10, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Opioids', 'Pain', 'Naloxone'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '12237198', 'type': 'BACKGROUND', 'citation': 'Anderson WS, Sheth RN, Bencherif B, Frost JJ, Campbell JN. Naloxone increases pain induced by topical capsaicin in healthy human volunteers. Pain. 2002 Sep;99(1-2):207-16. doi: 10.1016/s0304-3959(02)00103-3.'}, {'pmid': '10470716', 'type': 'BACKGROUND', 'citation': 'Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.'}, {'pmid': '11166937', 'type': 'BACKGROUND', 'citation': 'Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. 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J Neurosci. 2002 Jun 15;22(12):5100-7. doi: 10.1523/JNEUROSCI.22-12-05100.2002.'}, {'pmid': '37985872', 'type': 'DERIVED', 'citation': 'Khatib L, Dean JG, Oliva V, Riegner G, Gonzalez NE, Birenbaum J, Cruanes GF, Miller J, Patterson M, Kim HC, Chakravarthy K, Zeidan F. The role of endogenous opioids in mindfulness and sham mindfulness-meditation for the direct alleviation of evoked chronic low back pain: a randomized clinical trial. Neuropsychopharmacology. 2024 Jun;49(7):1069-1077. doi: 10.1038/s41386-023-01766-2. Epub 2023 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.', 'detailedDescription': 'The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis\n* Participants must be between 18 and 65 years of age\n* Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale\n* Participants must have experienced their chronic low back pain for at least 3 months\n* Participants must have no prior meditative experience\n* Participants must be straight leg raise test positive\n\nExclusion Criteria:\n\n* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period\n* Participants must not be taking opioids\n* Participants must not be pregnant or nursing mothers\n* Participants must have not had back surgery within the last year before their enrollment into the study\n* Participants must have not had any other sensory or motor deficits that preclude participation in this study\n* Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis\n* Participants must not have any known allergies to naloxone or similar drugs\n* Participants must not have a history of syncope and/or fear of needles/blood'}, 'identificationModule': {'nctId': 'NCT04034004', 'briefTitle': 'Chronic Low Back Pain and Meditation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief', 'orgStudyIdInfo': {'id': '190709'}, 'secondaryIdInfos': [{'id': 'R21AT010352', 'link': 'https://reporter.nih.gov/quickSearch/R21AT010352', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.', 'interventionNames': ['Behavioral: Mindfulness', 'Drug: Naloxone', 'Other: Saline', 'Behavioral: Meditation']}, {'type': 'EXPERIMENTAL', 'label': 'meditation', 'description': 'Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.', 'interventionNames': ['Behavioral: Mindfulness', 'Drug: Naloxone', 'Other: Saline', 'Behavioral: Meditation']}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'otherNames': ['mental training'], 'description': 'A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.', 'armGroupLabels': ['Meditation', 'meditation']}, {'name': 'Naloxone', 'type': 'DRUG', 'description': 'A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.', 'armGroupLabels': ['Meditation', 'meditation']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.', 'armGroupLabels': ['Meditation', 'meditation']}, {'name': 'Meditation', 'type': 'BEHAVIORAL', 'otherNames': ['mental training'], 'description': 'A well-validated brief meditation-based mental training regimen \\[four sessions; 20 min/session\\] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.', 'armGroupLabels': ['Meditation', 'meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical and Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Center for Mindfulness', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Fadel Zeidan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Fadel Zeidan', 'investigatorAffiliation': 'University of California, San Diego'}}}}