Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
adolescents, cigarettes, smoking, tobacco
Brief summary
Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.
Detailed description
Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies. Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion. Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment.
Interventions
DRUGBupropion-SR
150mg tablets taken orally twice daily for 9 weeks.
OTHERPlacebo
Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Has smoked at least 10 cigarettes each day for 3 or more months * Weighs at least 90 lbs * Motivated to quit smoking and has had at least one previous failed attempt * Speaks, reads, and writes English * Either diagnosed as depressed OR no history of a psychiatric disorder
Exclusion criteria
* History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry * Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry * Psychotic symptoms * Use of psychotropic medication(s) * Serious medical condition * Prior use of bupropion for smoking cessation * Currently using other smoking cessation treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Behavior | Nine weeks | Number of cigarettes smoked daily in the previous week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Symptoms | Nine weeks | Hughes-Hatsukami Withdrawal Scale |
Countries
United States
Participant flow
Recruitment details
Participants between ages 12 and 25 years who smoked at least 10 cigarettes per day over a period of 6 months were recruited between 2004 and 2010 through advertisements in local newspapers and flyers in local community agencies and primary care clinics.
Pre-assignment details
Participants completed an assessment for nicotine dependence and psychiatric disorders, and a laboratory stress study to assess baseline salivary cortisol over 2 hours and cortisol responses to a psychosocial stressor (public speaking and arithmetic tasks). Those who continued to meet study criteria were then randomized to active drug or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Active Drug (Bupropion-SR) Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks. | 71 |
| Matching Placebo Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks. | 73 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 11 |
| Overall Study | Withdrawal by Subject | 5 | 11 |
Baseline characteristics
| Characteristic | Active Drug (Bupropion-SR) | Matching Placebo | Total |
|---|---|---|---|
| Age, Continuous | 19.6 Years STANDARD_DEVIATION 3.2 | 18.3 Years STANDARD_DEVIATION 3.9 | 19.0 Years STANDARD_DEVIATION 3.6 |
| Daily smoking diary | 17.5 cigarettes/day in previous week STANDARD_DEVIATION 7.6 | 16.4 cigarettes/day in previous week STANDARD_DEVIATION 6.8 | 16.9 cigarettes/day in previous week STANDARD_DEVIATION 7.2 |
| Expired carbon monoxide | 13.9 Parts per million; higher worse STANDARD_DEVIATION 5.3 | 14.0 Parts per million; higher worse STANDARD_DEVIATION 8.9 | 13.9 Parts per million; higher worse STANDARD_DEVIATION 6.9 |
| Nicotine dependence | 5.6 units on a scale;range 0-9;higher worse STANDARD_DEVIATION 1.6 | 5.4 units on a scale;range 0-9;higher worse STANDARD_DEVIATION 1.3 | 5.5 units on a scale;range 0-9;higher worse STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Black : Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black : non-Hispanic | 9 Participants | 10 Participants | 19 Participants |
| Race/Ethnicity, Customized More than one race : Hispanic | 10 Participants | 12 Participants | 22 Participants |
| Race/Ethnicity, Customized More than one race : non-Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White : Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White : non-Hispanic | 52 Participants | 51 Participants | 103 Participants |
| Region of Enrollment United States | 71 participants | 73 participants | 144 participants |
| Sex: Female, Male Female | 38 Participants | 39 Participants | 77 Participants |
| Sex: Female, Male Male | 33 Participants | 34 Participants | 67 Participants |
| Withdrawal symptoms | 4.3 units on a scale;range 0-36;higher worse STANDARD_DEVIATION 3.3 | 4.1 units on a scale;range 0-36;higher worse STANDARD_DEVIATION 3.5 | 4.2 units on a scale;range 0-36;higher worse STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 73 |
| other Total, other adverse events | 7 / 71 | 8 / 73 |
| serious Total, serious adverse events | 0 / 71 | 0 / 73 |
Outcome results
Primary
Smoking Behavior
Number of cigarettes smoked daily in the previous week
Time frame: Nine weeks
Population: Analyzed all randomized participants with last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug (Bupropion-SR) | Smoking Behavior | 6.4 cigarettes/day in the previous week | Standard Deviation 4.3 |
| Matching Placebo | Smoking Behavior | 8.9 cigarettes/day in the previous week | Standard Deviation 5.4 |
Secondary
Withdrawal Symptoms
Hughes-Hatsukami Withdrawal Scale
Time frame: Nine weeks
Population: Analyzed all participants with last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug (Bupropion-SR) | Withdrawal Symptoms | 2.5 units on a scale;range0-36;higher worse | Standard Deviation 3.3 |
| Matching Placebo | Withdrawal Symptoms | 3.1 units on a scale;range0-36;higher worse | Standard Deviation 4.3 |