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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00342563
First received: June 19, 2006
Last updated: April 6, 2017
Last verified: April 2017
Results First Received: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: mecamylamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
  Description
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
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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
  Description
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 
Age 
[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
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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
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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
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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
e-mail: elizabeth.ralevski@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00342563     History of Changes
Other Study ID Numbers: HIC # 26364
Study First Received: June 19, 2006
Results First Received: October 24, 2016
Last Updated: April 6, 2017