A Phase 4 interventional study of Bupropion and Placebo in Tobacco Use Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.
988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.
This study's enrollment of 349 is above the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Bupropion SR and a weight concerns psychosocial intervention
Drug: Bupropion · Behavioral: weight concerns intervention
A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
Drug: Placebo · Behavioral: weight concerns intervention
Bupropion SR and a time and attention controlled smoking cessation intervention
Drug: Bupropion · Behavioral: smoking cessation intervention
A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
Drug: Placebo · Behavioral: smoking cessation intervention
smoking cessation medication aid
Also known as: zyban
A matched placebo pill
cognitive behavioral treatment to address weight concners
Cognitive behavioral intervention for smoking cessation
Smoking Abstinence
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
Smoking Abstinence
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
Smoking Abstinence
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
Women were recruited between September 1999 and October 2005.
| Milestone | 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 |
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.
| percentage of participants | WC+B | WC+P | SS+B | SS+P |
|---|---|---|---|---|
| Smoking Abstinence | 41 ± 1 | 18 | 33 | 19 |
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.
| percentage of participants | WC+B | WC+P | SS+B | SS+P |
|---|---|---|---|---|
| Smoking Abstinence | 34 | 11 | 21 | 10 |
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.
| percentage of participants | WC+B | WC+P | SS+B | SS+P |
|---|---|---|---|---|
| Smoking Abstinence | 24 | 8 | 19 | 7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WC+B | — | 0/106 (0%) | 0/106 (0%) |
| WC+P | — | 0/87 (0%) | 0/87 (0%) |
| SS+B | — | 0/89 (0%) | 0/89 (0%) |
| SS+P | — | 0/67 (0%) | 0/67 (0%) |
| Age, Categorical(Participants) | WC+B | WC+P | SS+B | SS+P | Total |
|---|---|---|---|---|---|
| <=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, Continuous(years) | WC+B | WC+P | SS+B | SS+P | Total |
|---|---|---|---|---|---|
| Mean | 42.1 ± 9.2 | 42.6 ± 10.0 | 41.0 ± 11.2 | 42.3 ± 10.4 | 42.0 ± 10.1 |
| Sex: Female, Male(Participants) | WC+B | WC+P | SS+B | SS+P | Total |
|---|---|---|---|---|---|
| Female | 106 | 87 | 89 | 67 | 349 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | WC+B | WC+P | SS+B | SS+P | Total |
|---|---|---|---|---|---|
| United States | 106 | 87 | 89 | 67 | 349 |
Plan to share: No
The record gives a start of Sep 2000, a primary completion of Dec 2009 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 3 years 11 months after primary completion.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupropion