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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion (Wellbutrin-SR) | Active Comparator | 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. |
|
| Matching Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion-SR | Drug | 150mg tablets taken orally twice daily for 9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Behavior | Number of cigarettes smoked daily in the previous week | Nine weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Symptoms | Hughes-Hatsukami Withdrawal Scale | Nine weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Rao, MD | University of Texas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 9101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug (Burpropion-SR) | In total 172 participants were recruited, and 144 were randomized. Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron's biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender. Participants 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. The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment. |
| FG001 | Matching Placebo | This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage. All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were between 12 and 25 years of age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Behavior | Number of cigarettes smoked daily in the previous week | Analyzed all randomized participants with last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | cigarettes/day in the previous week | Nine weeks |
|
Time frame for adverse events was over 9 weeks of treatment.
Adverse events were recorded based on Hughes-Hatsukami Withdrawal Scale and Side Effects Form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uma Rao, MD | The University of Tennessee | 615-794-3351 | urao@utk.edu |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Placebo | Other | Matching placebo (to Buproion-SR) twice daily for 9 weeks. |
|
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | The data were collected in Southwestern Region of the United States | Number | participants |
|
| Daily smoking diary | Number of cigarettes smoked per day | Mean | Standard Deviation | cigarettes/day in previous week |
|
| Withdrawal symptoms | Hughes-Hatsukami Withdrawal Scale | Mean | Standard Deviation | units on a scale;range 0-36;higher worse |
|
| Nicotine dependence | Fagerstrom Tolerance Questionnaire | Mean | Standard Deviation | units on a scale;range 0-9;higher worse |
|
| Expired carbon monoxide | Mean | Standard Deviation | Parts per million; higher worse |
|
|
|
| Secondary | Withdrawal Symptoms | Hughes-Hatsukami Withdrawal Scale | Analyzed all participants with last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale;range0-36;higher worse | Nine weeks |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 7 |
| 71 |
| EG001 | 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. | 0 | 73 | 0 | 73 | 8 | 73 |
| Negative affect | Psychiatric disorders | Systematic Assessment | negative mood/affect reported during the course of treatment |
|
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| D001523 |
| Mental Disorders |