Trial Outcomes & Findings for Effectiveness of Bupropion for Treating Nicotine Dependence in Young People (NCT NCT00129272)
NCT ID: NCT00129272
Last Updated: 2017-05-22
Results Overview
Number of cigarettes smoked daily in the previous week
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Nine weeks
Results posted on
2017-05-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
73
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
17
|
22
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
11
|
|
Overall Study
Withdrawal by Subject
|
5
|
11
|
Baseline Characteristics
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Baseline characteristics by cohort
| Measure |
Active Drug (Bupropion-SR)
n=71 Participants
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.
|
Matching Placebo
n=73 Participants
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.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.6 Years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
18.3 Years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
19.0 Years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black : non-Hispanic
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black : Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White : non-Hispanic
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White : Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race : non-Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race : Hispanic
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
73 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Daily smoking diary
|
17.5 cigarettes/day in previous week
STANDARD_DEVIATION 7.6 • n=5 Participants
|
16.4 cigarettes/day in previous week
STANDARD_DEVIATION 6.8 • n=7 Participants
|
16.9 cigarettes/day in previous week
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Withdrawal symptoms
|
4.3 units on a scale;range 0-36;higher worse
STANDARD_DEVIATION 3.3 • n=5 Participants
|
4.1 units on a scale;range 0-36;higher worse
STANDARD_DEVIATION 3.5 • n=7 Participants
|
4.2 units on a scale;range 0-36;higher worse
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Nicotine dependence
|
5.6 units on a scale;range 0-9;higher worse
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5.4 units on a scale;range 0-9;higher worse
STANDARD_DEVIATION 1.3 • n=7 Participants
|
5.5 units on a scale;range 0-9;higher worse
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Expired carbon monoxide
|
13.9 Parts per million; higher worse
STANDARD_DEVIATION 5.3 • n=5 Participants
|
14.0 Parts per million; higher worse
STANDARD_DEVIATION 8.9 • n=7 Participants
|
13.9 Parts per million; higher worse
STANDARD_DEVIATION 6.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Nine weeksPopulation: Analyzed all randomized participants with last observation carried forward (LOCF).
Number of cigarettes smoked daily in the previous week
Outcome measures
| Measure |
Active Drug (Bupropion-SR)
n=71 Participants
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.
|
Matching Placebo
n=73 Participants
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.
|
|---|---|---|
|
Smoking Behavior
|
6.4 cigarettes/day in the previous week
Standard Deviation 4.3
|
8.9 cigarettes/day in the previous week
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Nine weeksPopulation: Analyzed all participants with last observation carried forward (LOCF).
Hughes-Hatsukami Withdrawal Scale
Outcome measures
| Measure |
Active Drug (Bupropion-SR)
n=71 Participants
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.
|
Matching Placebo
n=73 Participants
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.
|
|---|---|---|
|
Withdrawal Symptoms
|
2.5 units on a scale;range0-36;higher worse
Standard Deviation 3.3
|
3.1 units on a scale;range0-36;higher worse
Standard Deviation 4.3
|
Adverse Events
Active Drug (Bupropion-SR)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Drug (Bupropion-SR)
n=71 participants at risk
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.
|
Matching Placebo
n=73 participants at risk
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.
|
|---|---|---|
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Gastrointestinal disorders
Nausea
|
9.9%
7/71 • Number of events 23 • 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.
|
8.2%
6/73 • Number of events 16 • 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.
|
|
Psychiatric disorders
Negative affect
|
4.2%
3/71 • Number of events 5 • 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.
|
11.0%
8/73 • Number of events 23 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place