Trial Outcomes & Findings for Combined Pharmaco/Behavior Therapy in Adolescent Smokers (NCT NCT00330187)
NCT ID: NCT00330187
Last Updated: 2018-10-02
Results Overview
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
End of treatment (week 6)
Results posted on
2018-10-02
Participant Flow
Participant milestones
| Measure |
Bupropion SR + Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
|
Placebo + Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Bupropion SR + No Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
|
Placebo + No Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
29
|
32
|
|
Overall Study
COMPLETED
|
17
|
18
|
11
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
18
|
14
|
Reasons for withdrawal
| Measure |
Bupropion SR + Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
|
Placebo + Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Bupropion SR + No Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
|
Placebo + No Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
13
|
14
|
10
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
4
|
4
|
Baseline Characteristics
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
Baseline characteristics by cohort
| Measure |
Bupropion SR + Contingency Management
n=37 Participants
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
|
Placebo + Contingency Management
n=36 Participants
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Bupropion SR + No Contingency Management
n=29 Participants
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
|
Placebo + No Contingency Management
n=32 Participants
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
62 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
72 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
18.4 years
STANDARD_DEVIATION 1.9 • n=93 Participants
|
18.4 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
18.1 years
STANDARD_DEVIATION 1.9 • n=27 Participants
|
19 years
STANDARD_DEVIATION 1.8 • n=483 Participants
|
18.5 years
STANDARD_DEVIATION 1.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
56 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
78 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: End of treatment (week 6)Population: Intent-to-treat analysis
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Outcome measures
| Measure |
Bupropion SR + Contingency Management
n=37 Participants
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
|
Placebo + Contingency Management
n=36 Participants
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Bupropion SR + No Contingency Management
n=29 Participants
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
|
Placebo + No Contingency Management
n=32 Participants
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
|---|---|---|---|---|
|
Biologically-verified 7-day Point Prevalence Smoking Abstinence
|
10 participants
|
3 participants
|
3 participants
|
3 participants
|
Adverse Events
Bupropion SR + Contingency Management
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo + Contingency Management
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Bupropion SR + No Contingency Management
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo + No Contingency Management
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion SR + Contingency Management
n=37 participants at risk
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
|
Placebo + Contingency Management
n=36 participants at risk
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Contingency Management: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
Bupropion SR + No Contingency Management
n=29 participants at risk
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Bupropion SR: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
|
Placebo + No Contingency Management
n=32 participants at risk
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Placebo: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
32.4%
12/37 • Number of events 12 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
13.9%
5/36 • Number of events 5 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
20.7%
6/29 • Number of events 6 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
15.6%
5/32 • Number of events 5 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • Number of events 2 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
0.00%
0/36 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
31.0%
9/29 • Number of events 9 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
15.6%
5/32 • Number of events 5 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
|
Psychiatric disorders
Irritability
|
21.6%
8/37 • Number of events 8 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
8.3%
3/36 • Number of events 3 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
17.2%
5/29 • Number of events 5 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
0.00%
0/32 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
|
Psychiatric disorders
Vivid dreams
|
2.7%
1/37 • Number of events 1 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
0.00%
0/36 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
27.6%
8/29 • Number of events 8 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
0.00%
0/32 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
|
General disorders
Other
|
10.8%
4/37 • Number of events 4 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
16.7%
6/36 • Number of events 6 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
10.3%
3/29 • Number of events 3 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
15.6%
5/32 • Number of events 5 • Full study period (randomization through week 12 post-treatment follow-up visit)
|
Additional Information
Kevin M. Gray, M.D.
Medical University of South Carolina
Phone: 843-792-6330
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place