Tobacco Use Disorder
Conditions
Keywords
smoking cessation, Women, bupropion, weight concerns, weight
Brief summary
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.
Detailed description
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.
Interventions
DRUGBupropion
smoking cessation medication aid
DRUGPlacebo
A matched placebo pill
BEHAVIORALweight concerns intervention
cognitive behavioral treatment to address weight concners
BEHAVIORALsmoking cessation intervention
Cognitive behavioral intervention for smoking cessation
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Smoke at least 10 cigarettes per day * Report concern about cessation-related weight gain * Motivated to quit smoking
Exclusion criteria
* Currently pregnant, lactating, or no medically approved method of contraception * Major medical problem * History of seizure disorder or head injury * Current or historical psychosis or bipolar disorder * History of alcohol or substance abuse within previous year * Current or historical eating disorder * Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month * Multiple Drug Allergies * Current major depressive disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 3 months | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| WC+B 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. | 106 |
| WC+P 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. | 87 |
| SS+B 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. | 89 |
| SS+P 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. | 67 |
| Total | 349 |
Baseline characteristics
| Characteristic | WC+P | SS+B | WC+B | SS+P | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants | 89 Participants | 106 Participants | 67 Participants | 349 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 10 | 41.0 years STANDARD_DEVIATION 11.2 | 42.1 years STANDARD_DEVIATION 9.2 | 42.3 years STANDARD_DEVIATION 10.4 | 42.0 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 87 participants | 89 participants | 106 participants | 67 participants | 349 participants |
| Sex: Female, Male Female | 87 Participants | 89 Participants | 106 Participants | 67 Participants | 349 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 87 | 0 / 89 | 0 / 67 |
| serious Total, serious adverse events | 0 / 106 | 0 / 87 | 0 / 89 | 0 / 67 |
Outcome results
Primary
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
Population: Participants with available data at 3mo. All others were unable to provide data at this time point.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| WC+B | Smoking Abstinence | 41 percentage of participants | 1 |
| WC+P | Smoking Abstinence | 18 percentage of participants | — |
| SS+B | Smoking Abstinence | 33 percentage of participants | — |
| SS+P | Smoking Abstinence | 19 percentage of participants | — |
p-value: 0.001Regression, Logistic
p-value: 0.25Regression, Logistic
p-value: 0.07Regression, Logistic
Primary
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
Population: Participants with available data at 6mo. All others were unable to provide data at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WC+B | Smoking Abstinence | 34 percentage of participants |
| WC+P | Smoking Abstinence | 11 percentage of participants |
| SS+B | Smoking Abstinence | 21 percentage of participants |
| SS+P | Smoking Abstinence | 10 percentage of participants |
p-value: <0.001Regression, Logistic
p-value: 0.053Regression, Logistic
p-value: 0.08Regression, Logistic
Primary
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
Population: Participants with available data at 12mo. All others were unable to provide data at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WC+B | Smoking Abstinence | 24 percentage of participants |
| WC+P | Smoking Abstinence | 8 percentage of participants |
| SS+B | Smoking Abstinence | 19 percentage of participants |
| SS+P | Smoking Abstinence | 7 percentage of participants |
p-value: 0.006Regression, Logistic
p-value: 0.45Regression, Logistic
p-value: 0.046Regression, Logistic