Nicotine DependencePhase 2NCT00330187
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
A Phase 2 study testing Bupropion SR and Contingency Management in people with Nicotine Dependence and Nicotine Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation… Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Nicotine Use Disorder
- What is being tested?
- Bupropion SR and Contingency Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
- Baseline urine cotinine level greater than 100 ng/ml.
- Age range of 12 - 21
- If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
- For post menarchal female participants: agree to use birth control to avoid pregnancy.
Who cannot join
- Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
- Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
- Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
- Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
- History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
- History of severe renal, hepatic, neurological, or chronic pulmonary disease. This criterion was chosen due to the hepatic metabolism of bupropion.
Show all 14Show fewer
- Unstable medical problems
- Allergy to bupropion
- Current treatment with any other medication containing bupropion
- Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2 weeks of starting the study since there may be serious and severe medical interactions between MAO inhibitors and bupropion SR.
- Current treatment with nicotine replacement therapy (NRT)
- History of intolerance or non-response to bupropion SR.
- Current (past month) suicide ideation
- Suicide attempt (past year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation outcomes AND retention of adolescent smokers in the study.
Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.
Read more
Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency management (CM) treatment will have increased retention and increased abstinence rates when compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased drop-out of participants, urine cotinine and continuous abstinence).
Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.
Read the detailed description
To test the hypotheses, 216 adolescent smokers will be recruited. Fifty-four adolescent smokers will be recruited in each of the four groups: bupropion SR only, bupropion SR + CM, CM + placebo, and placebo only. The cells will be balanced for gender and attention deficit hyperactivity disorder using permuted block randomization. A counseling intervention was added for all groups because it was reasoned that it would be unethical not to provide an active treatment to cigarette smoking adolescents. The counseling intervention will consist of two quit smoking brochures that provide information on tips to help quit smoking.
The study will consist of a one-week lead in period followed by a six-week treatment trial. For the medication groups, medications will be titrated during the one-week lead-in period. The primary outcome measure is urine cotinine and self-report of cigarette use collected using the Time-Line Follow-Back at the end of six weeks.
- Conditions
- Nicotine Dependence, Nicotine Use Disorder
- Being tested
- Bupropion SR, Contingency Management, Placebo
- Keywords
- nicotine dependence, bupropion SR, smoking cessation, adolescents, contingency management
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion SRDrug
Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Contingency ManagementBehavioural
Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
PlaceboOther
Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Bupropion SR + Contingency Management | Experimental | 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. Receives: Drug: Bupropion SR; Behavioral: Contingency Management |
| Placebo + Contingency Management | Active comparator | 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. Receives: Behavioral: Contingency Management; Other: Placebo |
| Bupropion SR + No Contingency Management | Active comparator | Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm. Receives: Drug: Bupropion SR |
| Placebo + No Contingency Management | Placebo comparator | Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologically-verified 7-day Point Prevalence Smoking Abstinence
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Measured: End of treatment (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startMar 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kevin Gray, MD, Medical University of South Carolina
- Investigators
- Himanshu P Upadhyaya, MS, MBBS, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330187
- Sponsor's protocol ID
- DA17460
- Other IDs
- R01DA017460
- Status last verified
- Sep 2018
- First submitted
- 25 May 2006
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 37230961Gray KM, Carpenter MJ, Baker NL, Hartwell KJ, Lewis AL, Hiott DW, Deas D, Upadhyaya HP. Bupropion SR and contingency management for adolescent smoking cessation. J Subst Abuse Treat. 2011 Jan;40(1):77-86. doi: 10.1016/j.jsat.2010.08.010. Epub 2010 Oct 8.
PubMed 20934835
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pharmaco/Behavior Therapy in Adolescent Smokers
- ClinicalTrials.gov ID
- NCT00330187
- Acronym / sponsor ID
- DA17460
- Conditions
- Nicotine Dependence, Nicotine Use Disorder
- Keywords
- nicotine dependence, bupropion SR, smoking cessation, adolescents, contingency management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2004 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 May 2006 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation outcomes AND retention of adolescent smokers in the study.
Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.
Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency management (CM) treatment will have increased retention and increased abstinence rates when compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased drop-out of participants, urine cotinine and continuous abstinence).
Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.
Detailed description
To test the hypotheses, 216 adolescent smokers will be recruited. Fifty-four adolescent smokers will be recruited in each of the four groups: bupropion SR only, bupropion SR + CM, CM + placebo, and placebo only. The cells will be balanced for gender and attention deficit hyperactivity disorder using permuted block randomization. A counseling intervention was added for all groups because it was reasoned that it would be unethical not to provide an active treatment to cigarette smoking adolescents. The counseling intervention will consist of two quit smoking brochures that provide information on tips to help quit smoking.
The study will consist of a one-week lead in period followed by a six-week treatment trial. For the medication groups, medications will be titrated during the one-week lead-in period. The primary outcome measure is urine cotinine and self-report of cigarette use collected using the Time-Line Follow-Back at the end of six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupropion SR + Contingency Management | Experimental | Drug: Bupropion SR, Behavioral: Contingency ManagementBupropion 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. |
| Placebo + Contingency Management | Active comparator | Behavioral: Contingency Management, Other: PlaceboPlacebo 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. |
| Bupropion SR + No Contingency Management | Active comparator | Drug: Bupropion SRBupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm. |
| Placebo + No Contingency Management | Placebo comparator | Other: PlaceboPlacebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
- Baseline urine cotinine level greater than 100 ng/ml.
- Age range of 12 - 21
- If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
- For post menarchal female participants: agree to use birth control to avoid pregnancy.
Key exclusion criteria (14 listed)
- Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
- Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
- Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
- Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
- History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion SRBupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment | Drug | Bupropion SR + Contingency Management, Bupropion SR + No Contingency Management |
| Contingency ManagementContingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence. | Behavioural | Bupropion SR + Contingency Management, Placebo + Contingency Management |
| PlaceboPlacebo, matched in appearance to Bupropion SR, for 6 weeks of treatment | Other | Placebo + Contingency Management, Placebo + No Contingency Management |
Primary outcome
Biologically-verified 7-day Point Prevalence Smoking Abstinence
Time frame: End of treatment (week 6)
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37230961Hajizadeh 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.
- Derived from this study: PubMed 20934835Gray KM, Carpenter MJ, Baker NL, Hartwell KJ, Lewis AL, Hiott DW, Deas D, Upadhyaya HP. Bupropion SR and contingency management for adolescent smoking cessation. J Subst Abuse Treat. 2011 Jan;40(1):77-86. doi: 10.1016/j.jsat.2010.08.010. Epub 2010 Oct 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Himanshu P Upadhyaya, MS, MBBS principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion SR and Contingency Management in people with Nicotine Dependence and Nicotine Use Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biologically-verified 7-day Point Prevalence Smoking Abstinence (time frame: End of treatment (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.