Phase 2
Completed N=136
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Alcoholism
Source: ClinicalTrials.gov NCT00342563 ↗
Enrolled (actual)
136
Serious AEs
3.7%
Results posted
May 2017
Primary outcomePrimary: Percent Heavy Drinking Days During Active Treatment Phase — 16.75; 24.28; 20.51; 21.78 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Heavy Drinking Days During Active Treatment Phase |
16.75; 24.28; 20.51; 21.78 | — |
| PRIMARY Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) |
8.772; 8.032; 10.575; 8.352; 6.969; 7.712 | — |
| PRIMARY Self-report Weekly Smoking Craving |
27.741; 28.047; 28.705; 28.273; 22.557; 24.032 | — |
| PRIMARY Self-report Average Number of Cigarettes Per Day |
8.055; 10.681 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00342563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.