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| ID | Type | Description | Link |
|---|---|---|---|
| R37AA014028 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Gabapentin treatment for alcohol dependence
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gabapentin 900mg daily | Experimental | 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. |
|
| gabapentin 1800mg daily | Experimental | 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks |
|
| placebo daily | Placebo Comparator | placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin 900mg | Drug | 900 mg gabapentin daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Mason, PhD | The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24190578 | Result | Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sample size estimate was derived from results of a prior trial that found an odds ratio of 2.96 for complete abstinence, estimating a sample size of 150 would show a medium effect size for the difference between gabapentin and placebo in rate of complete abstinence.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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). | All randomized subjects included in denominator for rate determination. | Posted | Number | participants | 12-week |
|
36 weeks
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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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Standard terminology | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | Standard terminology | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara J. Mason | The Scripps Research Institute | 858-784-7324 | mason@scripps.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 |
| D001521 | Behavior Therapy |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| behavioral counseling | Behavioral | 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 | Drug | lactose capsule compounded to mimic gabapentin capsules |
|
|
| gabapentin 1800mg | Drug | 1800 mg gabapentin daily for 12 weeks |
|
|
| 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. | 12-week |
| 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. | 12-week |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Meets Criteria for DSM-IV Alcohol Dependence | Meets DSM-IV criteria for current Alcohol Dependence defined as three or more symptoms of dependence. | Number | participants |
|
| OG001 |
| 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 |
| OG002 | 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 |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 12-week |
|
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 12-week |
|
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 12-week |
|
|
|
|
| 2 |
| 54 |
| 13 |
| 54 |
| EG001 | 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 | 0 | 47 | 9 | 47 |
| EG002 | 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 | 0 | 49 | 12 | 49 |
| Overnight Hospitalization | Investigations | Standard terminology | Systematic Assessment |
|
| Headache | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Standard terminology | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Standard terminology | Systematic Assessment |
|
| Depression | Psychiatric disorders | Standard terminology | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Standard terminology | Systematic Assessment |
|
| Increased hunger | Metabolism and nutrition disorders | Standard terminology | Systematic Assessment |
|
| Irritability | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Standard terminology | Systematic Assessment |
|
| Drowsy | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Dry Mouth | Nervous system disorders | Standard terminology | 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 |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |