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Bupropion SR Plus Counseling for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01621009
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Tobacco Dependence
Smoking
Interventions Drug: Active bupropion + counseling
Drug: Active bupropion, No counseling
Drug: Placebo medication + counseling
Drug: Placebo medication, No counseling
Enrollment 463
Recruitment Details Participants recruited from Madison, WI area through TV, radio, newspaper advertisements from January, 2001 to October 2002
Pre-assignment Details Participants were 1) phone screened, 2) invited to group orientation where signed consent was obtained, and 3) completed CO testing and office visit for physical exam. Participants were considered enrolled after passing all 3 steps and randomization occurred at enrollment.
Arm/Group Title Active Bupropion + Counseling Active Bupropion , No Counseling Placebo Medication + Counseling Placebo Medication, No Counseling
Hide Arm/Group Description Active bupropion SR plus eight 10-minute individual counseling sessions. Active bupropion, No counseling, only medication checks Placebo bupropion plus eight 10-minute individual counseling sessions Placebo bupropion, No counseling, just medication checks
Period Title: Overall Study
Started 113 116 121 113
Completed 70 65 58 60
Not Completed 43 51 63 53
Arm/Group Title Active Bupropion + Counseling Active Bupropion , No Counseling Placebo Medication + Counseling Placebo Medication, No Counseling Total
Hide Arm/Group Description Active bupropion SR plus eight 10-minute individual counseling sessions. Active bupropion, No counseling, only medication checks Placebo bupropion plus eight 10-minute individual counseling sessions Placebo bupropion, No counseling, just medication checks Total of all reporting groups
Overall Number of Baseline Participants 113 116 121 113 463
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 121 participants 113 participants 463 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
113
 100.0%
116
 100.0%
121
 100.0%
113
 100.0%
463
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 116 participants 121 participants 113 participants 463 participants
36.76  (11.39) 41.03  (12.64) 37.82  (12.82) 39.42  (11.34) 38.76  (12.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 121 participants 113 participants 463 participants
Female
52
  46.0%
57
  49.1%
63
  52.1%
61
  54.0%
233
  50.3%
Male
61
  54.0%
59
  50.9%
58
  47.9%
52
  46.0%
230
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 113 participants 116 participants 121 participants 113 participants 463 participants
113 116 121 113 463
7-day point prevalence abstinence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 121 participants 113 participants 463 participants
Abstinent 21 16 15 14 66
Not Abstinent 92 100 106 99 397
[1]
Measure Description: Participants provided breath samples for carbon monoxide(CO)testing at all visits and provided a blood sample to assess cotinine (the first metabolite of nicotine)levels at baseline and again at end of treatment.
1.Primary Outcome
Title 7-day Point Prevalence Abstinence From Smoking at 6 Months
Hide Description No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full intent-to-treat sample
Arm/Group Title Bupropion + Counseling Bupropion, No Counseling Placebo + Counseling Placebo, No Counseling
Hide Arm/Group Description:

Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.

Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions

Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.

: Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.

Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions

: Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.

No cessation counseling, medication management and assessment only.

Overall Number of Participants Analyzed 113 116 121 113
Measure Type: Number
Unit of Measure: Number of abstinent participants
21 16 15 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion + Counseling, Placebo, No Counseling
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
.78 to 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bupropion + Counseling, Bupropion, No Counseling
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
.52 to 2.44
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Medication Active Medication
Hide Arm/Group Description Medications: Pre-quit – one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date. Pre-quit – 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
All-Cause Mortality
Placebo Medication Active Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Medication Active Medication
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/234 (0.00%)      0/229 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo Medication Active Medication
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/234 (28.21%)      94/229 (41.05%)    
Nervous system disorders     
depression *  25/234 (10.68%)  25 15/229 (6.55%)  15
insomnia *  10/234 (4.27%)  10 35/229 (15.28%)  35
Headache *  5/234 (2.14%)  5 14/229 (6.11%)  14
Psychiatric disorders     
Feeling jittery *  5/234 (2.14%)  5 11/229 (4.80%)  11
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection *  21/234 (8.97%)  21 19/229 (8.30%)  19
*
Indicates events were collected by non-systematic assessment
Lack of a no-treatment control condition; limited ability to generalize to broader population
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Baker, PhD, Director of Research
Organization: University of Wisconsin Center for Tobacco Research and Intervention
Phone: (608) 262-7568
EMail: tbb@ctri.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01621009    
Other Study ID Numbers: 1998-369
P50CA084724 ( U.S. NIH Grant/Contract )
P50DA019706 ( U.S. NIH Grant/Contract )
First Submitted: June 13, 2012
First Posted: June 15, 2012
Results First Submitted: May 27, 2015
Results First Posted: January 27, 2016
Last Update Posted: January 27, 2016