Gabapentin for Abstinence Initiation in Alcohol Dependence
GAINS
1 other identifier
interventional
40
1 country
2
Brief Summary
Primary Hypotheses: 1\. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the 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 method. Secondary Hypotheses: 1\. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
July 18, 2018
CompletedApril 24, 2019
April 1, 2019
2.3 years
June 9, 2010
June 20, 2018
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Heavy Drinking Days Per Week
percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
assesed over 8 weeks, presented for week 8 of trial
Secondary Outcomes (1)
Percent Days of Abstinence From Alcohol
assessed for up to 8 weeks, presented at week 8 of trial
Study Arms (2)
Gabapentin
ACTIVE COMPARATORGabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Placebo
PLACEBO COMPARATORPlacebo capsules will be administered TID.
Interventions
During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
Eligibility Criteria
You may qualify if:
- Between the ages of 18-65.
- Meets DSM-IV criteria for current alcohol dependence.
- Seeking treatment for alcohol dependence.
- 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.
- Able to provide informed consent and comply with study procedures.
You may not qualify if:
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.
- A diagnosis of current major depressive disorder or any other current Axis I psychiatric disorder as defined by DSM-IV-TR, other than alcohol dependence, that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- Patients currently taking prescribed psychotropic medications that would be disrupted by study medication or by an effort to discontinue alcohol use.
- Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar \> 13.
- History of allergic reaction to candidate medication (gabapentin).
- History of alcohol withdrawal seizures or alcohol withdrawal delirium.
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men.
- Unstable medical conditions, such as poorly controlled diabetes or hypertension (\> 140/90 mm Hg), which might make participation hazardous.
- Are legally mandated to participate in an alcohol use disorder treatment program.
- Who by history and current assessment represent a significant risk for suicide.
- Subjects who are likely, based on history, to place themselves in danger (e.g., driving while intoxicated or otherwise being unwilling to follow safety precautions).
- Renal insufficiency or abnormal renal function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Substance Treatment and Research Service (STARS)
New York, New York, 10019, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Mariani JJ, Pavlicova M, Basaraba C, Mamczur-Fuller A, Brooks DJ, Bisaga A, Carpenter KM, Nunes EV, Levin FR. Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder. Alcohol Clin Exp Res. 2021 Aug;45(8):1639-1652. doi: 10.1111/acer.14648. Epub 2021 Jul 5.
PMID: 34120336DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- john mariani md
- Organization
- NYSPI
Study Officials
- PRINCIPAL INVESTIGATOR
John Mariani, MD
NYSPI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research psychiatrist
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 10, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 24, 2019
Results First Posted
July 18, 2018
Record last verified: 2019-04