Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
165 participants
INTERVENTIONAL
2013-08-31
2021-12-31
Brief Summary
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1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
3. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.
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Detailed Description
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Participants in Phase 1 will be randomized to one of two brief interventions based on standard of care guidelines (SoC): A) brief counseling and bupropion (SoC); or B) SoC plus brief high-magnitude prize CM (HM-CM). At the end of Phase 1, participants will be classified as responders or non-responders on the basis of smoking reduction/abstinence. All participants will continue to receive bupropion. Non-responders will enter Phase 2a and be randomly assigned to: A) continued counseling and monitoring support to quit smoking (MS); or B) MS plus prize CM for abstinence (MS+CM). Phase 1 responders will be entered into Phase 2b and randomly assigned to: A) no additional treatment (NAT); or B) Continued monitoring and low intensity prize CM (LI-CM). The primary dependent variables will include cotinine and carbon monoxide (CO) levels, and longest duration of abstinence from cigarettes. Seven-day point prevalence will be used to assess outcome at post-treatment, 6-month and 12-month follow-up points.
Participants will be paid $35 for intake and $25 for each follow-up interview, which will occur at post-phase 1, post-phase 2, and 6-months and 12-months after treatment initiation. Some assessments as well as treatment sessions will be recorded to ensure data quality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: Standard of Care (A)
Brief counseling and bupropion
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Brief Counseling
Participants are provided with brief counseling for smoking cessation.
High-magnitude prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Prize contingency management for abstinence
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Phase 2b: Responders (A)
Bupropion, no additional treatment.
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
No additional treatment
No additional treatment will be given.
Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Low intensity prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Interventions
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Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Brief Counseling
Participants are provided with brief counseling for smoking cessation.
High-magnitude prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
No additional treatment
No additional treatment will be given.
Prize contingency management for abstinence
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Low intensity prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to read and understand English
3. Smoke more than 10 cigarettes/day
4. Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
Exclusion Criteria
2. Are in recovery for pathological gambling (PG)
3. Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
4. Are already participating in other smoking cessation interventions.
18 Years
80 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Wayne State University
OTHER
Responsible Party
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David Ledgerwood
Associate Professor
Principal Investigators
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David Ledgerwood, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Tolan Park Medical Building
Detroit, Michigan, United States
Countries
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References
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Ledgerwood DM, Lundahl LH, Greenwald MK, Cohn J, Arfken CL. Prize-Based Incentives for Smoking Cessation Among People With HIV: A Sequential Multiple Assignment Randomized Trial. Nicotine Tob Res. 2025 Apr 22;27(5):893-902. doi: 10.1093/ntr/ntae243.
Other Identifiers
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