Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-01-28 @ 4:24 PM
Study NCT ID:
NCT02423018
Status:
TERMINATED
Last Update Posted:
2016-03-23
First Post:
2015-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Low enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in score on the Benzodiazepine Withdrawal Symptom Questionnaire', 'timeFrame': 'Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)'}, {'measure': 'Change in score on the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)'}, {'measure': 'Clinical Global Impression Scale - Severity', 'timeFrame': 'Day 0'}, {'measure': 'Clinical Global Impression Scale - Improvement', 'timeFrame': 'Day 10'}, {'measure': 'Benzodiazepine use post-discharge', 'timeFrame': '30 days post-discharge', 'description': 'Assess benzodiazepine use since discharge'}, {'measure': 'Pregabalin use post-discharge', 'timeFrame': '30 days post-discharge', 'description': 'Assess pregabalin use since discharge'}], 'primaryOutcomes': [{'measure': 'Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Profile of Mood States (POMS)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Psychomotor Performance (Digit Symbol Substitution Test (DSST)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Digit Symbol Substitution Test (DSST)'}, {'measure': 'Visual Analogue Scale for "Take Drug Again"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Any Drug Effects"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Good Effects"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Bad Effects"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Feel Sick"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Nausea"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Sleepy"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Visual Analogue Scale for "Dizzy"', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose'}, {'measure': 'Sedation (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Euphoria (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Dysphoric Changes (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Psychotomimetic Changes (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Somatic Disturbances (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Sensory Disturbances (Addiction Research Center Inventory (ARCI)', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Addiction Research Center Inventory (ARCI)'}, {'measure': 'Tmax Estimated peak plasma pregabalin concentration', 'timeFrame': 'On Days 6 and 8 only: obtained 1 hour post-dose', 'description': 'Estimated peak plasma pregabalin concentration'}, {'measure': 'Change from baseline on Visual Analogue Scale for "Drug High" over 5 hours', 'timeFrame': 'On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose', 'description': 'Additional Primary Outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Substance-Related Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.camh.ca/en/research/Pages/research.aspx', 'label': 'The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a single dose of pregabalin 300mg in patients receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful differences in measures of "drug liking" and "drug high" as compared to placebo.', 'detailedDescription': "Pregabalin is currently being explored as a pharmacotherapy for substance use disorders. Open-labeled, uncontrolled studies indicate modest efficacy of pregabalin in benzodiazepine withdrawal symptom management and as a long-term benzodiazepine dependence treatment. Concurrently, there is increasing information from case reports and adverse drug event registries regarding pregabalin abuse in patients with substance use disorders.\n\nGiven that the abuse liability of pregabalin has not been clearly established, nor its effects on benzodiazepine withdrawal symptoms in inpatients, this study is a randomized, double-blind, placebo-controlled, cross-over, abuse liability study of a single dose of pregabalin 300mg, nested within a randomized,double-blind placebo-controlled, feasibility study evaluating pregabalin's effects on withdrawal symptoms in inpatients undergoing medically-assisted withdrawal from benzodiazepine, zopiclone or zolpidem."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the Medical Withdrawal Unit at the Centre for Addiction and Mental Health for medically assisted withdrawal from benzodiazepines, zopiclone and/or zolpidem\n* Willing and capable to give written informed consent\n\nExclusion Criteria:\n\n* Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.\n* Pregnant or nursing women\n* Renal impairment (creatinine clearance less than 60ml/min)\n* History of angioedema, or taking drugs associated with angioedema (e.g., ACE-inhibitors).\n* Currently taking pregabalin or gabapentin\n* Currently taking thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone)\n* Previous history of pregabalin or gabapentin abuse'}, 'identificationModule': {'nctId': 'NCT02423018', 'briefTitle': 'Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': "Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal", 'orgStudyIdInfo': {'id': '079-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days', 'interventionNames': ['Drug: Pregabalin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 10 days', 'interventionNames': ['Drug: Pregabalin', 'Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.', 'armGroupLabels': ['Placebo', 'Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.', 'armGroupLabels': ['Placebo', 'Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3M2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Beth Sproule, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician Scientist', 'investigatorFullName': 'Beth Sproule', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}