Gabapentin for Abstinence Initiation in Alcohol Dependence | RxWiki

Gabapentin for Abstinence Initiation in Alcohol Dependence

Overview[ - collapse ][ - ]

Purpose	Primary Hypotheses: 1. Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to placebo. The primary outcome measure of alcohol withdrawal will be the Clinical Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, & Sellers, 1989) score. 2. 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 secondary outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.
Condition	Alcohol Dependence
Intervention	Drug: Gabapentin Other: Placebo
Phase	Phase 2/Phase 3
Sponsor	New York State Psychiatric Institute
Responsible Party	New York State Psychiatric Institute
ClinicalTrials.gov Identifier	NCT01141049
First Received	June 9, 2010
Last Updated	January 15, 2014
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	June 9, 2010
Last Updated Date	January 15, 2014
Start Date	August 2010
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	The number of days of abstinence from alcohol [Time Frame: 8 weeks of trial or length of patient's participation] [Designated as safety issue: No]During the course of 8 weeks the medication aims to determine whether it is effective in treating alcohol withdrawal symptoms, reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Gabapentin for Abstinence Initiation in Alcohol Dependence
Official Title	Gabapentin for Abstinence Initiation in Alcohol Dependence
Brief Summary	Primary Hypotheses: 1. Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to placebo. The primary outcome measure of alcohol withdrawal will be the Clinical Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, & Sellers, 1989) score. 2. 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 secondary outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.
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 treatment of alcohol withdrawal as measured by the CIWA-Ar and 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.)
Study Type	Interventional
Study Phase	Phase 2/Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Alcohol Dependence
Intervention	Drug: 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. Other Names: NeurontinOther: Placebo Placebo, TID
Study Arm (s)	Active Comparator: 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. Placebo Comparator: Placebo Placebo capsules will be administered TID.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01141049
Other Study ID Numbers	#6123
Has Data Monitoring Committee	Yes
Information Provided By	New York State Psychiatric Institute
Study Sponsor	New York State Psychiatric Institute
Collaborators	Not Provided
Investigators	Principal Investigator: John Mariani, MD NYSPI
Verification Date	July 2013

Locations[ + expand ][ + ]