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Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304707
First Posted: March 20, 2006
Last Update Posted: May 15, 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):
David Kalman, National Institute on Drug Abuse (NIDA)
Results First Submitted: April 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Smoking Cessation
Alcohol-Related Disorders
Interventions: Drug: Bupropion
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
Bupropion 300-mg Capsules

participants in this arm receive bupropion

Bupropion: 300 mg QD

Placebo

placebo

placebo: placebo


Participant Flow:   Overall Study
    Bupropion 300-mg Capsules   Placebo
STARTED   73   70 
COMPLETED   66   64 
NOT COMPLETED   7   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.
No text entered.

Reporting Groups
  Description
Bupropion 300-mg Capsules

participants in this arm receive bupropion

Bupropion: 300 mg QD

Placebo

placebo

placebo: placebo

Total Total of all reporting groups

Baseline Measures
   Bupropion 300-mg Capsules   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   70   143 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.2  (7.5)   47.8  (10.5)   48.6  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  20.5%      11  15.7%      26  18.2% 
Male      58  79.5%      59  84.3%      117  81.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      20  27.4%      16  22.9%      36  25.2% 
White      53  72.6%      54  77.1%      107  74.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   73   70   143 


  Outcome Measures

1.  Primary:   Smoking Abstinence   [ Time Frame: week 7, week 11 and week 24 after scheduled quit day ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Kalman, PhD
Organization: University of Massachusetts Medical School
phone: 9785782371
e-mail: kalmand@comcast.net



Responsible Party: David Kalman, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00304707     History of Changes
Other Study ID Numbers: R01DA017370 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2006
First Posted: March 20, 2006
Results First Submitted: April 5, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017