Bupropion and Weight Control for Smoking Cessation - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marsha Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00006170
First received: August 9, 2000
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Drug: Bupropion

  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
Women were recruited between September 1999 and October 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Potential participants were excluded for current MDD, suicidality, drug or alcohol dependence within the past year, psychotic disorders, conditions associated with lowered seizure threshold, use of medications contraindicated with bupropion, uncontrolled hypertension, recent use of bupropion, pregnancy or use of other smoking or weight treatments.

Reporting Groups
  Description
Weight Concerns + Bupropion (WC+B) An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
Weight Concerns + Placebo (WC+P) An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
Social Support + Bupropion (SS+B) An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
Social Support + Placebo (SS+P) An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.

Participant Flow:   Overall Study
    Weight Concerns + Bupropion (WC+B)     Weight Concerns + Placebo (WC+P)     Social Support + Bupropion (SS+B)     Social Support + Placebo (SS+P)  
STARTED     106     87     89     67  
COMPLETED     57     37     46     28  
NOT COMPLETED     49     50     43     39  



  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
WC+B An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
WC+P An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
SS+B An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
SS+P An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
Total Total of all reporting groups

Baseline Measures
    WC+B     WC+P     SS+B     SS+P     Total  
Number of Participants  
[units: participants]
  106     87     89     67     349  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     106     87     89     67     349  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.1  ± 9.2     42.6  ± 10.0     41.0  ± 11.2     42.3  ± 10.4     42.0  ± 10.1  
Gender  
[units: participants]
         
Female     106     87     89     67     349  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     106     87     89     67     349  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Smoking Abstinence   [ Time Frame: 3 months ]

2.  Primary:   Smoking Abstinence   [ Time Frame: 6 months ]

3.  Primary:   Smoking Abstinence   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Michele Levine
Organization: University of Pittsburgh
phone: 412-647-0703
e-mail: levinem@upmc.edu


No publications provided by University of Pittsburgh

Publications automatically indexed to this study:

Responsible Party: Marsha Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00006170     History of Changes
Other Study ID Numbers: NIDA-04174-1, R01DA004174, R01-04174-1
Study First Received: August 9, 2000
Results First Received: June 18, 2013
Last Updated: November 18, 2013
Health Authority: United States: Federal Government