Alcoholism, Alcohol Dependence
Conditions
Keywords
Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence
Brief summary
Gabapentin treatment for alcohol dependence
Detailed description
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.
Interventions
DRUGGabapentin 900mg
900 mg gabapentin daily for 12 weeks
BEHAVIORALbehavioral counseling
The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
DRUGplacebo
lactose capsule compounded to mimic gabapentin capsules
DRUGgabapentin 1800mg
1800 mg gabapentin daily for 12 weeks
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Scripps Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over age 18 with alcohol dependence
Exclusion criteria
* Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances * Significant medical disorders that will increase potential risk or interfere with study participation * Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control * Treatment with an investigational drug in the last month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinking | 12-week | Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood | 12-week | Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups. |
| Sleep | 12-week | The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups. |
| Craving | 12-week | Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin 900mg Daily 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info. | 54 |
| Gabapentin 1800mg Daily 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks | 47 |
| Placebo Daily placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placebo: lactose capsule compounded to mimic gabapentin capsules | 49 |
| Total | 150 |
Baseline characteristics
| Characteristic | Gabapentin 900mg Daily | Gabapentin 1800mg Daily | Placebo Daily | Total |
|---|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 10.1 | 45.2 years STANDARD_DEVIATION 11.3 | 46.8 years STANDARD_DEVIATION 11.3 | 44.6 years STANDARD_DEVIATION 10.9 |
| Meets Criteria for DSM-IV Alcohol Dependence | 54 participants | 47 participants | 49 participants | 150 participants |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 28 Participants | 65 Participants |
| Sex: Female, Male Male | 33 Participants | 31 Participants | 21 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 54 | 9 / 47 | 12 / 49 |
| serious Total, serious adverse events | 2 / 54 | 0 / 47 | 0 / 49 |
Outcome results
Primary
Drinking
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Time frame: 12-week
Population: All randomized subjects included in denominator for rate determination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin 900mg Daily | Drinking | 6 participants |
| Gabapentin 1800mg Daily | Drinking | 8 participants |
| Placebo Daily | Drinking | 2 participants |
Comparison: The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.p-value: <0.04Mantel Haenszel
Comparison: The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.p-value: <0.02Mantel Haenszel
Secondary
Craving
Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.
Time frame: 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin 900mg Daily | Craving | 33.66 units on a scale | Standard Error 0.78 |
| Gabapentin 1800mg Daily | Craving | 32.31 units on a scale | Standard Error 0.82 |
| Placebo Daily | Craving | 34.27 units on a scale | Standard Error 0.7 |
p-value: <0.003ANOVA
Secondary
Mood
Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Time frame: 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin 900mg Daily | Mood | 5.08 units on a scale | Standard Error 0.53 |
| Gabapentin 1800mg Daily | Mood | 3.62 units on a scale | Standard Error 0.44 |
| Placebo Daily | Mood | 5.40 units on a scale | Standard Error 0.39 |
p-value: <0.001ANOVA
Secondary
Sleep
The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Time frame: 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin 900mg Daily | Sleep | 4.04 units on a scale | Standard Error 0.2 |
| Gabapentin 1800mg Daily | Sleep | 3.24 units on a scale | Standard Error 0.17 |
| Placebo Daily | Sleep | 4.50 units on a scale | Standard Error 0.22 |
p-value: <0.001ANOVA