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Bupropion and Weight Control for Smoking Cessation - 1

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ClinicalTrials.gov Identifier: NCT00006170
Recruitment Status : Completed
First Posted : August 10, 2000
Results First Posted : November 14, 2013
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marsha Marcus, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Interventions Drug: Bupropion
Drug: Placebo
Behavioral: weight concerns intervention
Behavioral: smoking cessation intervention
Enrollment 349
Recruitment Details Women were recruited between September 1999 and October 2005.
Pre-assignment Details 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.
Arm/Group Title Weight Concerns + Bupropion (WC+B) Weight Concerns + Placebo (WC+P) Social Support + Bupropion (SS+B) Social Support + Placebo (SS+P)
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 106 87 89 67
Completed 57 37 46 28
Not Completed 49 50 43 39
Arm/Group Title WC+B WC+P SS+B SS+P Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 106 87 89 67 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 87 participants 89 participants 67 participants 349 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
106
 100.0%
87
 100.0%
89
 100.0%
67
 100.0%
349
 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 106 participants 87 participants 89 participants 67 participants 349 participants
42.1  (9.2) 42.6  (10.0) 41.0  (11.2) 42.3  (10.4) 42.0  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 87 participants 89 participants 67 participants 349 participants
Female
106
 100.0%
87
 100.0%
89
 100.0%
67
 100.0%
349
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 87 participants 89 participants 67 participants 349 participants
106 87 89 67 349
1.Primary Outcome
Title Smoking Abstinence
Hide Description Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at 3mo. All others were unable to provide data at this time point.
Arm/Group Title WC+B WC+P SS+B SS+P
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 70 39 56 37
Measure Type: Number
Unit of Measure: percentage of participants
41 18 33 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WC+B, WC+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WC+B, SS+B
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SS+B, SS+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Smoking Abstinence
Hide Description Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at 6mo. All others were unable to provide data at this time point.
Arm/Group Title WC+B WC+P SS+B SS+P
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 64 40 47 32
Measure Type: Number
Unit of Measure: percentage of participants
34 11 21 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WC+B, WC+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WC+B, SS+B
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SS+B, SS+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Primary Outcome
Title Smoking Abstinence
Hide Description Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at 12mo. All others were unable to provide data at this time point.
Arm/Group Title WC+B WC+P SS+B SS+P
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 37 46 28
Measure Type: Number
Unit of Measure: percentage of participants
24 8 19 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WC+B, WC+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection WC+B, SS+B
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SS+B, SS+P
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title WC+B WC+P SS+B SS+P
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
WC+B WC+P SS+B SS+P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
WC+B WC+P SS+B SS+P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/87 (0.00%)   0/89 (0.00%)   0/67 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
WC+B WC+P SS+B SS+P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/87 (0.00%)   0/89 (0.00%)   0/67 (0.00%) 
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: Dr. Michele Levine
Organization: University of Pittsburgh
Phone: 412-647-0703
Responsible Party: Marsha Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00006170     History of Changes
Other Study ID Numbers: NIDA-04174-1
R01DA004174 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2000
First Posted: August 10, 2000
Results First Submitted: June 18, 2013
Results First Posted: November 14, 2013
Last Update Posted: July 21, 2016