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Trial record 3 of 3 for:    "Nasopharyngeal Carcinoma" | "Dopamine Uptake Inhibitors"

Bupropion in Helping Adults Stop Smoking

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ClinicalTrials.gov Identifier: NCT00534001
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   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
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1-week Run In (Standard) 4-week Run-in (Extended)
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 48 47
Completed 43 43
Not Completed 5 4
Arm/Group Title Arm I (1-week run-in) Arm II (4-week run-in) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 48 47 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 95 participants
46.7  (9.3) 45.8  (10.1) 46  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Female
26
  54.2%
24
  51.1%
50
  52.6%
Male
22
  45.8%
23
  48.9%
45
  47.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Racial/Ethnic Minority
5
  10.4%
4
   8.5%
9
   9.5%
White/Not Hispanic
43
  89.6%
43
  91.5%
86
  90.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 48 participants 47 participants 95 participants
48
 100.0%
47
 100.0%
95
 100.0%
Cigarettes Smoked Per Day (CPD)  
Mean (Standard Deviation)
Unit of measure:  CPD
Number Analyzed 48 participants 47 participants 95 participants
22.0  (6.0) 23.4  (7.9) 23  (7)
1.Primary Outcome
Title Prequit Change in Cigarettes Per Day
Hide Description Prequit Change in Cigarettes Per Day
Time Frame 3-Week PreQuit Drug Manipulation Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)
Arm/Group Title Arm I (1-week run-in) Arm II (4-week run-in)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 46 46
Mean (Standard Error)
Unit of Measure: Cigarettes Per Day
-2.6  (0.5) -3.9  (0.6)
2.Secondary Outcome
Title Abstinence
Hide Description Bioverified 4-week continuous abstinence
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (1-week run-in) Arm II (4-week run-in)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 48 47
Measure Type: Count of Participants
Unit of Measure: Participants
25
  52.1%
15
  31.9%
Time Frame 8 weeks
Adverse Event Reporting Description Only participant-volunteered side effects were noted.
 
Arm/Group Title Arm I (1-week run-in) Arm II (4-week run-in)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (1-week run-in) Arm II (4-week run-in)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)      0/47 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (1-week run-in) Arm II (4-week run-in)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/47 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (1-week run-in) Arm II (4-week run-in)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/48 (100.00%)      47/47 (100.00%)    
General disorders     
Any Non-Serious Adverse Event * [1]  48/48 (100.00%)  48 47/47 (100.00%)  47
*
Indicates events were collected by non-systematic assessment
[1]
Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.
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
Layout table for Results Point of Contact information
Name/Title: Martin Mahoney
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
EMail: martin.mahoney@roswellpark.org
Layout table for additonal information
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 )
First Submitted: September 20, 2007
First Posted: September 24, 2007
Results First Submitted: February 20, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017