Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
1 other identifier
interventional
136
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedJune 4, 2019
May 1, 2019
11.2 years
June 19, 2006
October 24, 2016
May 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percent Heavy Drinking Days During Active Treatment Phase
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.
12 weeks
Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)
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.
12 weeks
Self-report Weekly Smoking Craving
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.
12 weeks
Self-report Average Number of Cigarettes Per Day
self-report from only the smoking population for cigarettes per day
12 weeks
Study Arms (4)
Mecamylamine- Smoker
EXPERIMENTALPlacebo-Smoker
PLACEBO COMPARATORMecamylamine- Non-Smoker
EXPERIMENTALPlacebo-Non-Smoker
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (1)
Gandelman E, Petrakis I, Kachadourian L, Ralevski E. Negative Affect Intensity and Hostility in Individuals With Alcohol Use Disorder With or Without Posttraumatic Stress Disorder. J Dual Diagn. 2018 Apr-Jun;14(2):96-101. doi: 10.1080/15504263.2018.1434264. Epub 2018 Apr 25.
PMID: 29461925DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Elizabeth Ralevski
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Ismene Petrakis, M.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
May 1, 2004
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
June 4, 2019
Results First Posted
May 17, 2017
Record last verified: 2019-05