Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-18 @ 7:42 PM
Study NCT ID:
NCT03268551
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2017-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEMO-Medical Marijuana and Opioids Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid analgesic use', 'timeFrame': 'Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.', 'description': 'The primary outcome will combine measures of prescribed and illicit opioid analgesic use.'}], 'secondaryOutcomes': [{'measure': 'Alternative measures of opioid analgesic use', 'timeFrame': 'Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.', 'description': 'Alternative measures of opioid analgesic use will include: number of days of all opioid analgesic use, mean daily dose of all opioid analgesics, cumulative dose of prescribed (only) opioid analgesics, number of days of prescribed (only) opioid analgesic use, and mean daily dose of prescribed (only) opioid analgesic use.'}, {'measure': 'HIV viral load', 'timeFrame': 'HIV outcomes will be measured seven times every 3 months from baseline through 18 months.', 'description': 'HIV viral load will be measured in copies/ml from blood samples collected during the study.'}, {'measure': 'CD4 count', 'timeFrame': 'CD4 count will be measured seven times every 6 months from baseline through 18 months..', 'description': 'CD4 count will be measured in cells/mm3 from blood samples collected during the study.'}, {'measure': 'HIV antiretroviral adherence', 'timeFrame': 'HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..', 'description': 'HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.'}, {'measure': 'HIV risk behaviors', 'timeFrame': 'HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..', 'description': 'HIV risk behaviors will be a composite measure from self-reported questionnaires.'}, {'measure': 'Cannabis use disorder', 'timeFrame': 'Cannabis use disorder will be measured three times every 6 months.', 'description': 'Cannabis use disorder will be measured using standardized instruments.'}, {'measure': 'Illicit drug use', 'timeFrame': 'Illicit drug use will be measured seven times every 3 months from baseline through 18 months..', 'description': 'Illicit drug use will be measured using standardized surveys and urine toxicology testing.'}, {'measure': 'Diversion of medical cannabis', 'timeFrame': 'Diversion will be measured seven times every 3 months from baseline through 18 months..', 'description': 'Diversion will be measured using standardized surveys.'}, {'measure': 'Non-fatal overdose', 'timeFrame': 'Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..', 'description': 'Non-fatal overdose will be measured using standardized surveys.'}, {'measure': 'Death', 'timeFrame': 'Death will be measured 18 months after enrollment.', 'description': 'Death will be ascertained from the National Death Index'}, {'measure': 'Accidents/Injuries', 'timeFrame': 'Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..', 'description': 'Accidents/Injuries will be measured using standardized survey instruments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Marijuana', 'Chronic Pain', 'HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '36961410', 'type': 'DERIVED', 'citation': 'Zhang C, Slawek DE, Ross J, Zolotov Y, Castillo F, Levin FR, Sohler NL, Minami H, Cunningham CO, Starrels JL, Arnsten JH. Factors Associated with Medical Cannabis Use After Certification: A Three-Month Longitudinal Study. Cannabis Cannabinoid Res. 2024 Jun;9(3):e859-e869. doi: 10.1089/can.2022.0248. Epub 2023 Mar 24.'}, {'pmid': '33376181', 'type': 'DERIVED', 'citation': 'Cunningham CO, Starrels JL, Zhang C, Bachhuber MA, Sohler NL, Levin FR, Minami H, Slawek DE, Arnsten JH. Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain. BMJ Open. 2020 Dec 29;10(12):e043400. doi: 10.1136/bmjopen-2020-043400.'}], 'seeAlsoLinks': [{'url': 'https://bmjopen.bmj.com/content/10/12/e043400', 'label': 'Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain'}, {'url': 'https://doi.org/10.1016/j.jpsychires.2021.12.001', 'label': 'Pain catastrophizing and mental health phenotypes in adults with refractory chronic pain: A latent class analysis'}]}, 'descriptionModule': {'briefSummary': 'The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events.', 'detailedDescription': 'The overarching goal of the study is to understand how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis. Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week time period (unit of analysis), the primary exposure measure will be number of days of medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative findings will help understand the reasons underlying the findings of the cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* English or Spanish fluency\n* New certification for medical cannabis within 90 days\n* No medical cannabis use in the 6 months prior to certification\n* Medical cannabis qualifying complication of "chronic or severe pain"\n* Use of prescribed or illicit opioid analgesics within 30 days\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to complete study visits over 18 months\n* Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson\'s disease, inflammatory bowel disease, Hungtington\'s disease)\n* Terminal illness\n* Current or prior psychotic disorder'}, 'identificationModule': {'nctId': 'NCT03268551', 'briefTitle': 'MEMO-Medical Marijuana and Opioids Study', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?', 'orgStudyIdInfo': {'id': '2017-7857'}, 'secondaryIdInfos': [{'id': '1R01DA044171-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA044171-01A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Health System', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10601', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Vireo Health', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fordham University', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}