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Bupropion in Helping Adults Stop Smoking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00534001
First received: September 20, 2007
Last updated: April 24, 2017
Last verified: August 2015
Results First Received: February 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Other
Conditions: Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Interventions: Drug: bupropion hydrochloride
Other: 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
1-week Run In (Standard) No text entered.
4-week Run-in (Extended) No text entered.

Participant Flow:   Overall Study
    1-week Run In (Standard)   4-week Run-in (Extended)
STARTED   48   47 
COMPLETED   43   43 
NOT COMPLETED   5   4 



  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.
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Reporting Groups
  Description
Arm I (1-week run-in)

Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.

bupropion hydrochloride: Given orally

placebo: Given orally

Arm II (4-week run-in)

Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.

bupropion hydrochloride: Given orally

Total Total of all reporting groups

Baseline Measures
   Arm I (1-week run-in)   Arm II (4-week run-in)   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   47   95 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.7  (9.3)   45.8  (10.1)   46  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26  54.2%      24  51.1%      50  52.6% 
Male      22  45.8%      23  48.9%      45  47.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Racial/Ethnic Minority   5   4   9 
White/Not Hispanic   43   43   86 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   48   47   95 
Cigarettes Smoked Per Day (CPD) 
[Units: CPD]
Mean (Standard Deviation)
 22.0  (6.0)   23.4  (7.9)   23  (7) 


  Outcome Measures
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1.  Primary:   Prequit Change in Cigarettes Per Day   [ Time Frame: 3-Week PreQuit Drug Manipulation Phase ]

2.  Secondary:   Abstinence   [ Time Frame: 4 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:  
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: Martin Mahoney
Organization: Roswell Park Cancer Institute
phone: 716-845-2300
e-mail: martin.mahoney@roswellpark.org



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00534001     History of Changes
Other Study ID Numbers: CDR0000565103
I 57805 ( Other Identifier: Roswell Park Cancer Institute )
Study First Received: September 20, 2007
Results First Received: February 20, 2017
Last Updated: April 24, 2017