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

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. Identifier: NCT00342563
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : May 17, 2017
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: mecamylamine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Mecamylamine- Smoker mecamylamine: mecamylamine 10mg/day
Mecamylamine Non-Smoker No text entered.
Placebo Smoker No text entered.
Placebo Non-Smoker No text entered.

Participant Flow:   Overall Study
    Mecamylamine- Smoker   Mecamylamine Non-Smoker   Placebo Smoker   Placebo Non-Smoker
STARTED   41   27   40   28 
COMPLETED   35   19   26   22 
NOT COMPLETED   6   8   14   6 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One hundred and thirty six (136) individuals were randomized in this study with equal number of participants assigned to treatment (n=68) and placebo (n=68) groups. Randomization was stratified by gender and smoking status.

Reporting Groups
Mecamylamine-Smoker mecamylamine: mecamylamine 10mg/day
Mecamylamine-Non-Smoker No text entered.
Placebo-Smoker Placebo: Placebo
Placebo- Non-Smoker No text entered.
Total Total of all reporting groups

Baseline Measures
   Mecamylamine-Smoker   Mecamylamine-Non-Smoker   Placebo-Smoker   Placebo- Non-Smoker   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   27   40   28   136 
[Units: Years]
Mean (Standard Deviation)
 45.83  (8.42)   50.93  (9.55)   47.28  (8.69)   51.14  (10.28)   48.4  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      6  14.6%      4  14.8%      6  15.0%      4  14.3%      20  14.7% 
Male      35  85.4%      23  85.2%      34  85.0%      24  85.7%      116  85.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Black   17   14   18   18   67 
White   23   13   21   10   67 
Other   1   0   1   0   2 
Veteran Status 
[Units: Participants]
Veteran   19   9   18   8   54 
Non-Veteran   22   18   22   20   82 

  Outcome Measures

1.  Primary:   Percent Heavy Drinking Days During Active Treatment Phase   [ Time Frame: 12 weeks ]

2.  Primary:   Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)   [ Time Frame: 12 weeks ]

3.  Primary:   Self-report Weekly Smoking Craving   [ Time Frame: 12 weeks ]

4.  Primary:   Self-report Average Number of Cigarettes Per Day   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Elizabeth Ralevski
Organization: Yale University School of Medicine
phone: +1 203-932-5711 ext x4282

Responsible Party: Yale University Identifier: NCT00342563     History of Changes
Other Study ID Numbers: 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: January 17, 2018