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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00342563
First received: June 19, 2006
Last updated: January 14, 2014
Last verified: January 2014
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • self-report weekly alcohol consumption and smoking [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • self-report weekly craving [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • self-report weekly smoking craving [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2004
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Mecamylamine Drug: mecamylamine
mecamylamine 10mg/day

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342563

Contacts
Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282 elizabeth.ralevski@yale.edu
Contact: Ismene Petrakis, M.D. 203-932-5711 ext 2244 ismene.petrakis@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Ismene Petrakis, M.D.    203-932-5711 ext 2244    ismene.petrakis@yale.edu   
Contact: Elizabeth Ralevski, Ph.D.    203-932-5711 ext 4282    elizabeth.ralevski@yale.edu   
Principal Investigator: Ismene Petrakis, M.D.         
Sponsors and Collaborators
Elizabeth Ralevski
Investigators
Principal Investigator: Ismene Petrakis, M.D. Yale University
  More Information

No publications provided

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00342563     History of Changes
Other Study ID Numbers: HIC # 26364
Study First Received: June 19, 2006
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
mecamylamine
treatment
alcohol dependence
smoking

Additional relevant MeSH terms:
Alcoholism
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Food Habits
Habits
Mecamylamine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014