Status:
COMPLETED
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Lead Sponsor:
Yale University
Conditions:
Alcoholism
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol consumption in smoking and non-smoking alcohol dependent patients. We hypothesize that mecamylamine will ...
Detailed Description
RESEARCH PLAN: Although there are two FDA approved medications for the treatment of alcohol dependence (naltrexone and disulfiram), the robust efficacy of both compounds in reducing alcohol consumptio...
Eligibility Criteria
Inclusion
- individuals with DSM-IV diagnosis of alcohol dependence
- smokers and non-smokers
- patients who do not require psychotropic medication for the management of their psychiatric symptoms
- individuals with a history of substance dependence (other than alcohol and tobacco) but have not met criteria for substance dependence in the past 30 days
- women with acceptable method of contraception
Exclusion
- pregnant women
- medications thought to influence drinking behavior including: acamprosate, disulfiram, naltrexone and ondansetron
- underlying medical conditions
- history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine
- DSM-IV diagnosis of bipolar disorder, schizophrenia, and schizophrenia-type disorders
- unstable medical conditions
- patients who require psychotropic medication for the management of an active psychiatric disorder
- patients on pharmacological treatment for alcohol and/or nicotine dependence
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00342563
Start Date
May 1 2004
End Date
July 1 2015
Last Update
June 4 2019
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516