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Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00342563
First Posted: June 21, 2006
Last Update Posted: May 17, 2017
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.
Information provided by (Responsible Party):
Yale University
  Purpose

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.


Condition Intervention Phase
Alcoholism Drug: mecamylamine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percent Heavy Drinking Days During Active Treatment Phase [ Time Frame: 12 weeks ]
    Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) average during 90 days of treatment.

  • Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: 12 weeks ]
    The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.

  • Self-report Weekly Smoking Craving [ Time Frame: 12 weeks ]
    Questionnaire of smoking urges (QSU). It has 32 questions that range from 1 to 7, there are 8 questions per sub-scale. The total range is 32 to 224. Each sub-scale ranges from 8- 56, with a higher score indicating higher craving.

  • Self-report Average Number of Cigarettes Per Day [ Time Frame: 12 weeks ]
    self-report from only the smoking population for cigarettes per day


Enrollment: 136
Study Start Date: May 2004
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mecamylamine- Smoker Drug: mecamylamine
mecamylamine 10mg/day
Placebo Comparator: Placebo-Smoker Drug: Placebo
Placebo
Experimental: Mecamylamine- Non-Smoker Drug: mecamylamine
mecamylamine 10mg/day
Placebo Comparator: Placebo-Non-Smoker Drug: Placebo
Placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT00342563


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Ismene Petrakis, M.D. Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00342563     History of Changes
Other Study ID Numbers: HIC # 26364
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: October 24, 2016
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017

Keywords provided by Yale University:
mecamylamine
treatment
alcohol dependence
smoking

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Mecamylamine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action