Alcohol Dependence
Conditions
Keywords
Alcohol Withdrawal, Reducing Alcohol Consumption, Promoting abstinence in alcohol-dependent patients, Gabapentin
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.
Detailed description
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.)
Interventions
DRUGGabapentin
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.
OTHERPlacebo
Placebo, TID
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine dependence. A diagnosis of substance abuse will not be exclusionary unless significant illicit substance use is present. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Heavy Drinking Days Per Week | assesed over 8 weeks, presented for week 8 of trial | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Days of Abstinence From Alcohol | assessed for up to 8 weeks, presented at week 8 of trial | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Placebo Placebo capsules will be administered TID.
Placebo: Placebo, TID | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo | Total | Gabapentin |
|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 8.7 | 48.1 years STANDARD_DEVIATION 9.1 | 46.2 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 29 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 15 / 19 | 11 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
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.
Time frame: assesed over 8 weeks, presented for week 8 of trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Percent of Heavy Drinking Days Per Week | 22.5 percent of heavy drinking days | Standard Deviation 34 |
| Placebo | Percent of Heavy Drinking Days Per Week | 53.9 percent of heavy drinking days | Standard Deviation 44 |
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.
Time frame: assessed for up to 8 weeks, presented at week 8 of trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Percent Days of Abstinence From Alcohol | 50 percent of days abstinent | Standard Deviation 37 |
| Placebo | Percent Days of Abstinence From Alcohol | 27.5 percent of days abstinent | Standard Deviation 38 |