- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322305
Pregabalin Trial for the Treatment of Alcohol Use Disorder (GABI2)
A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study 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
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Daniel Brooks, MSW
- Phone Number: 646-774-8181
- Email: daniel.brooks@nyspi.columbia.edu
Study Contact Backup
- Name: elizabeth martinez
- Phone Number: 212-923-3030
- Email: elizabeth.martinez@nyspi.columbia.edu
Study Locations
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New York
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New York, New York, United States, 10019
- Nyspi-Stars
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets DSM-5 criteria for current alcohol use disorder
- 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
- Between the ages of 18 and 65
- Able to provide informed consent and comply with study procedures
Exclusion Criteria:
- 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.
- Evidence of moderate-to-severe alcohol withdrawal Clinical Institute Withdrawal Assessment (revised version) (CIWA-Ar score ≥10)
- History of alcohol withdrawal seizures or alcohol withdrawal delirium
- History of allergic reaction to candidate medication (pregabalin)
- Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods
- Unstable physical disorders which might make participation hazardous
- 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.
- Are legally mandated to participate in alcohol use disorder treatment program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregabalin
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.
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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.
Other Names:
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Placebo Comparator: Placebo
Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.
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Placebo capsules will be provided twice daily over 8 weeks and one week taper..
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of heavy drinking days
Time Frame: measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation
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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.
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measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation
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Collaborators and Investigators
Investigators
- Principal Investigator: john mariani, MD, New York Psychiatric Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 7977 (CTEP)
- R21AA028371 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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