Gabapentin Treatment of Alcohol Dependence
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00391716 |
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Recruitment Status :
Completed
First Posted : October 24, 2006
Results First Posted : November 10, 2014
Last Update Posted : November 10, 2014
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Sponsor:
The Scripps Research Institute
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
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Brief Summary:
Gabapentin treatment for alcohol dependence
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcoholism Alcohol Dependence | Drug: Gabapentin 900mg Behavioral: behavioral counseling Drug: placebo Drug: gabapentin 1800mg | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Gabapentin Treatment of Alcohol Dependence |
| Study Start Date : | February 2004 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | February 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Alcohol Use Disorder (AUD)
| Arm | Intervention/treatment |
|---|---|
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Experimental: gabapentin 900mg daily
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
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Drug: Gabapentin 900mg
900 mg gabapentin daily for 12 weeks
Other Name: Neurontin Behavioral: 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.
Other Name: alcoholfree.info |
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Experimental: gabapentin 1800mg daily
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
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Behavioral: 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.
Other Name: alcoholfree.info Drug: gabapentin 1800mg 1800 mg gabapentin daily for 12 weeks
Other Name: Neurontin |
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Placebo Comparator: placebo daily
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
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Behavioral: 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.
Other Name: alcoholfree.info Drug: placebo lactose capsule compounded to mimic gabapentin capsules
Other Name: lactose capsule |
Primary Outcome Measures :
- Drinking [ Time Frame: 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 Outcome Measures :
- Mood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391716
Locations
| United States, California | |
| The Scripps Research Institute | |
| La Jolla, California, United States, 92037 | |
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
| Principal Investigator: | Barbara J. Mason, PhD | The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research |
Publications of Results:
| Responsible Party: | Barbara J. Mason, PI, The Scripps Research Institute |
| ClinicalTrials.gov Identifier: | NCT00391716 |
| Other Study ID Numbers: |
NIAAAMAS014028 R37AA014028 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 24, 2006 Key Record Dates |
| Results First Posted: | November 10, 2014 |
| Last Update Posted: | November 10, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Barbara J. Mason, The Scripps Research Institute:
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Alcohol Alcohol treatment Alcoholism Alcohol Dependence |
Additional relevant MeSH terms:
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Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |