Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

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 result in a greater reduction of alcohol consumption
      than placebo. We further hypothesize that mecamylamine will be effective in reducing both
      alcohol consumption and smoking in a subset of alcoholics who also smoke.
    

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 consumption has recently been called into question. Given the high rates of alcohol
      dependence among the general population, development and testing of novel medications is of
      great importance.

      Mecamylamine, a noncompetitive NACh receptor antagonist has been shown to be useful in
      smoking cessation when used in combination with transdermal nicotine. To our knowledge,
      clinical studies examining the effectiveness of mecamylamine in alcoholism have not been
      conducted. However, there is evidence from animal research that mecamylamine can block the
      effects of alcohol. Infusion of mecamylamine into the ventral tegmental area antagonized
      ethanol-induced dopamine release in rats. More importantly, mecamylamine decreased alcohol
      intake and preference in alcohol-preferring rats. In two studies with healthy volunteers
      mecamylamine was effective in attenuating the euphoric effects of alcohol and reducing the
      craving for alcohol.

      This is the first study designed to test the clinical efficacy of mecamylamine in a sample of
      alcohol dependent patients who either do or do not smoke.

      For the proposed project we will recruit 60 treatment seeking patients between the ages of 18
      and 60 who meet criteria for alcohol dependence and may or may not smoke. Patients will be
      randomized into two groups (30 patients in each group): one dose of mecamylamine (10mg) or
      placebo in a double-blind fashion for 12 weeks. Patients will be asked to come for follow up
      3 months after completing the study. Patients will be excluded if they: take medications
      thought to influence drinking behavior, have a significant underlying medical conditions,
      such as cerebral, renal, thyroid, hepatic or cardiac pathology; have a history of glaucoma,
      prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis, or
      a history of hypersensitivity to mecamylamine; or meet current criteria for Bipolar
      Disorders, Schizophrenia and Schizophrenia-type Disorders, Major Depression or Posttraumatic
      Stress Disorders (PTSD). Females who are pregnant or lactating will also be excluded.

      We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption
      than placebo among the alcohol dependent patients. We further hypothesize that mecamylamine
      will be effective in reducing both alcohol consumption and smoking in a subgroup of
      alcoholics who also smoke.
    

Intervention name(s): mecamylamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): mecamylamine 10mg/day; Placebo
Intervention MeSH terms: Mecamylamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mecamylamine; treatment; alcohol dependence; smoking