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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.
In an 8-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of gabapentin in the treatment of alcohol dependence will be studied in 60 patients. Participants will be randomly assigned to treatment under double-blind conditions with either 1) a fixed dosing schedule of gabapentin or 2) placebo. All participants will receive weekly supportive behavioral treatment that promotes abstinence from alcohol and other substances, encourages mutual-support meeting attendance, and facilitates compliance with study medication. The primary outcome measures will be: the reduction of heavy drinking days per week as measured by the timeline follow-back method.
Participants will be alcohol-dependent men and nonpregnant women who 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. The daily minimum drinking requirements are consistent with the commonly accepted definition of "binge drinking." A minimum requirement of having a heavy drinking episode 4 days a week would select for a population of individuals who are drinking excessively more days than not. A minimum threshold of weekly alcohol use is set to prevent a "floor effect" (i.e. participants with minimal alcohol use at baseline would be unable to demonstrate significant improvement.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Gabapentin 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 Comparator | Placebo capsules will be administered TID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days of Abstinence From Alcohol | During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients. | assessed for up to 8 weeks, presented at week 8 of trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Mariani, MD | NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Treatment and Research Service (STARS) | New York | New York | 10019 | United States | ||
| New York State Psychiatric Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34120336 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin 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. Gabapentin: 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. |
| FG001 | Placebo | Placebo capsules will be administered TID. Placebo: Placebo, TID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin 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. Gabapentin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent of heavy drinking days | assesed over 8 weeks, presented for week 8 of trial |
|
during 8 weeks of trial or participant's length of participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | Gabapentin 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. Gabapentin: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| john mariani md | NYSPI | 646-774-6140 | john.mariani@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Placebo | Other | Placebo, TID |
|
| New York |
| New York |
| 10032 |
| United States |
| BG001 | Placebo | Placebo capsules will be administered TID. Placebo: Placebo, TID |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo capsules will be administered TID. Placebo: Placebo, TID |
|
|
| Secondary | Percent Days of Abstinence From Alcohol | During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients. | Posted | Mean | Standard Deviation | percent of days abstinent | assessed for up to 8 weeks, presented at week 8 of trial |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 15 |
| 19 |
| EG001 | Placebo | Placebo capsules will be administered TID. Placebo: Placebo, TID | 0 | 21 | 0 | 21 | 11 | 21 |
| anxiety | General disorders | Systematic Assessment |
|
| appetite change | Gastrointestinal disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| gi upset | Gastrointestinal disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| libido changes | General disorders | Systematic Assessment |
|
| muscle pain/weakness | General disorders | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| somnolence | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |