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Combined Pharmaco/Behavior Therapy in Adolescent Smokers

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ClinicalTrials.gov Identifier: NCT00330187
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nicotine Dependence
Nicotine Use Disorder
Interventions Drug: Bupropion SR
Behavioral: Contingency Management
Other: Placebo
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Hide Arm/Group Description

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 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 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 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

Period Title: Overall Study
Started 37 36 29 32
Completed 17 18 11 18
Not Completed 20 18 18 14
Reason Not Completed
Lost to Follow-up             12             13             14             10
Withdrawal by Subject             8             5             4             4
Arm/Group Title Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management Total
Hide Arm/Group Description

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 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 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 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 of all reporting groups
Overall Number of Baseline Participants 37 36 29 32 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 29 participants 32 participants 134 participants
<=18 years
17
  45.9%
16
  44.4%
14
  48.3%
15
  46.9%
62
  46.3%
Between 18 and 65 years
20
  54.1%
20
  55.6%
15
  51.7%
17
  53.1%
72
  53.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 36 participants 29 participants 32 participants 134 participants
18.4  (1.9) 18.4  (1.9) 18.1  (1.9) 19  (1.8) 18.5  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 29 participants 32 participants 134 participants
Female
16
  43.2%
14
  38.9%
11
  37.9%
15
  46.9%
56
  41.8%
Male
21
  56.8%
22
  61.1%
18
  62.1%
17
  53.1%
78
  58.2%
1.Primary Outcome
Title Biologically-verified 7-day Point Prevalence Smoking Abstinence
Hide Description Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Time Frame End of treatment (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis
Arm/Group Title Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Hide Arm/Group Description:

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 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 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 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 Number of Participants Analyzed 37 36 29 32
Measure Type: Number
Unit of Measure: participants
10 3 3 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion SR + Contingency Management, Placebo + No Contingency Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
0.9 to 14.4
Estimation Comments [Not Specified]
Time Frame Full study period (randomization through week 12 post-treatment follow-up visit)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Hide Arm/Group Description

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 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 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 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

All-Cause Mortality
Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)      0/36 (0.00%)      0/29 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/36 (0.00%)      0/29 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupropion SR + Contingency Management Placebo + Contingency Management Bupropion SR + No Contingency Management Placebo + No Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/37 (59.46%)      14/36 (38.89%)      25/29 (86.21%)      15/32 (46.88%)    
General disorders         
Other   4/37 (10.81%)  4 6/36 (16.67%)  6 3/29 (10.34%)  3 5/32 (15.63%)  5
Nervous system disorders         
Headache   12/37 (32.43%)  12 5/36 (13.89%)  5 6/29 (20.69%)  6 5/32 (15.63%)  5
Psychiatric disorders         
Insomnia   2/37 (5.41%)  2 0/36 (0.00%)  0 9/29 (31.03%)  9 5/32 (15.63%)  5
Irritability   8/37 (21.62%)  8 3/36 (8.33%)  3 5/29 (17.24%)  5 0/32 (0.00%)  0
Vivid dreams   1/37 (2.70%)  1 0/36 (0.00%)  0 8/29 (27.59%)  8 0/32 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin M. Gray, M.D.
Organization: Medical University of South Carolina
Phone: 843-792-6330
EMail: graykm@musc.edu
Layout table for additonal information
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00330187    
Other Study ID Numbers: DA17460
R01DA017460 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2006
First Posted: May 26, 2006
Results First Submitted: September 7, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 2, 2018