Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04322305
Status:
SUSPENDED
Last Update Posted:
2025-02-14
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregabalin Trial for the Treatment of Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Double blind, placebo controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in proportion of heavy drinking days', 'timeFrame': "measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation", 'description': 'Change in heavy drinking days as quantified by the proportion of heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back (TLFB) method.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol use disorder', 'treatment', 'pregabalin'], 'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'In a 10-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of pregabalin in the treatment of alcohol dependence will be studied in 50 treatment-seeking outpatients. Participants will report drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days.', 'detailedDescription': 'In a 10-week double-blind placebo controlled outpatient clinical trial, the safety and efficacy ofpregabalin will be tested in 50 outpatients with Alcohol Use Disorder.Participants will be randomly allocated (1:1) to receive pregabalin or an identical-appearing, inert placebo. All study medication (placebo and pregabalin) will be over-capsulated with riboflavin to assess compliance. Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules. Pregabalin will be titrated over a 3-week period to the FDA maximum (600 mg per day) or the maximum tolerated dose.\n\nStudy visits will occur daily for the first 4 days of the study period, then approximately every other day for the remainder of week 1, for a total of 5 study visits (study days 1,2,3,4, and 5 or 7). During the second week, study visits will continue every other day for a total of 3 study visits (study days 8,10, and 12). During the remainder of the 8-week medication study period, study visits will occur twice weekly. There will be two visits during a post-study taper week (week 9) and a follow-up visit during week 10. One visit per week will be with the research psychiatrist. All participants will have a weekly supportive behavioral treatment session with the research psychiatrist using a manual designed for pharmacotherapy trials in subjects with alcohol use disorders'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets DSM-5 criteria for current alcohol use disorder\n* Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days\n* Between the ages of 18 and 65\n* Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Subjects with any current psychiatric disorder as defined by DSM-5, other than Alcohol use disorder, that in the investigator's judgment likely requiring ongoing dosage adjustments of their current medications or requiring changes in their medication and/or might require intervention over the course of the study, including schizophrenia, schizoaffective disorder, psychotic disorders other than transient psychosis due to drug abuse, bipolar disorder, and current suicidality with plan and intent. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (pregabalin). The medications being allowed are commonly used antidepressants, including the SSRIs (e.g., fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram), SNRI's (e.g., venlafaxine, desvenlafaxine, duloxetine), and bupropion.\n* Evidence of moderate-to-severe alcohol withdrawal Clinical Institute Withdrawal Assessment (revised version) (CIWA-Ar score ≥10)\n* History of alcohol withdrawal seizures or alcohol withdrawal delirium\n* History of allergic reaction to candidate medication (pregabalin)\n* Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods\n* Unstable physical disorders which might make participation hazardous\n* Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine dependence. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol dependence.\n* Are legally mandated to participate in alcohol use disorder treatment program"}, 'identificationModule': {'nctId': 'NCT04322305', 'acronym': 'GABI2', 'briefTitle': 'Pregabalin Trial for the Treatment of Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '7977'}, 'secondaryIdInfos': [{'id': 'R21AA028371', 'link': 'https://reporter.nih.gov/quickSearch/R21AA028371', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'description': 'Treatment with pregabalin administered in 75 mg and 100 capsules in dosages up to 600 mg per day for up to 8 weeks (including a 3 week titration run up) followed by a one week taper.', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Pregabalin will be provided in 75 and 100 mg capsules twice daily for a maximum dose of 600 mg/day or the maximum tolerated dose over the 8 week medication phase and followed by a one week taper.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsules will be provided twice daily over 8 weeks and one week taper..', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Nyspi-Stars', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'john mariani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Psychiatric Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'beginning 12 months and ending 5 years after article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)', 'accessCriteria': 'to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Psychiatrist', 'investigatorFullName': 'John Mariani MD', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}