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Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT00304707
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
David Kalman, National Institute on Drug Abuse (NIDA)

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
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion 300-mg Capsules Placebo
Hide Arm/Group Description

participants in this arm receive bupropion

Bupropion: 300 mg QD

placebo

placebo: placebo

Period Title: Overall Study
Started 73 70
Completed 66 64
Not Completed 7 6
Arm/Group Title Bupropion 300-mg Capsules Placebo Total
Hide Arm/Group Description

participants in this arm receive bupropion

Bupropion: 300 mg QD

placebo

placebo: placebo

Total of all reporting groups
Overall Number of Baseline Participants 73 70 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 70 participants 143 participants
49.2  (7.5) 47.8  (10.5) 48.6  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 70 participants 143 participants
Female
15
  20.5%
11
  15.7%
26
  18.2%
Male
58
  79.5%
59
  84.3%
117
  81.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 70 participants 143 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 73 participants 70 participants 143 participants
73 70 143
1.Primary Outcome
Title Smoking Abstinence
Hide Description The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.
Time Frame week 7, week 11 and week 24 after scheduled quit day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion 300-mg Capsules Placebo
Hide Arm/Group Description:

participants in this arm receive bupropion

Bupropion: 300 mg QD

placebo

placebo: placebo

Overall Number of Participants Analyzed 73 70
Measure Type: Number
Unit of Measure: participants
week 7 19 21
week 11 12 9
week 24 6 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion 300-mg Capsules Placebo
Hide Arm/Group Description

participants in this arm receive bupropion

Bupropion: 300 mg QD

placebo

placebo: placebo

All-Cause Mortality
Bupropion 300-mg Capsules Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion 300-mg Capsules Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Bupropion 300-mg Capsules Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/73 (9.59%)   2/70 (2.86%) 
Cardiac disorders     
Rise in systolic blood pressure   0/73 (0.00%)  1/70 (1.43%) 
Endocrine disorders     
Dry mouth   2/73 (2.74%)  1/70 (1.43%) 
Nervous system disorders     
insomnia   5/73 (6.85%)  2/70 (2.86%) 
Indicates events were collected by systematic assessment
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
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 )
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