Clinical trial NCT02349477: Gabapentin for Alcohol Relapse Prevention
Official title: Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Alcohol Withdrawal
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

Detailed description: This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

Eligibility criteria: Inclusion Criteria:

1. Meets criteria for alcohol use disorder based on DSM-5 criteria
2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria:

1. Significant psychiatric or medical illness
2. No other substance abuse
3. Taking other medications known to treat alcohol use disorder
4. Unstable living arrangements
5. Significant legal problems pending

Primary outcomes:
measure: Percent of Subjects With no Heavy Drinking Days (PSNHDD)
timeFrame: 4 months
Secondary outcomes:
measure: Percent of Subjects With no Drinking Days (PSNDD)
timeFrame: 4 months
Other outcomes:
measure: Number of Participants With No Drinking Days by AWS Score and Medication
timeFrame: 4 months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Raymond F Anton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prisciandaro JJ, Hoffman M, Brown TR, Voronin K, Book S, Bristol E, Anton RF. Effects of Gabapentin on Dorsal Anterior Cingulate Cortex GABA and Glutamate Levels and Their Associations With Abstinence in Alcohol Use Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):829-837. doi: 10.1176/appi.ajp.2021.20121757. Epub 2021 Jul 14.
citation: Anton RF, Latham P, Voronin K, Book S, Hoffman M, Prisciandaro J, Bristol E. Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):728-736. doi: 10.1001/jamainternmed.2020.0249.