HIVNCT01965405
Smoking Cessation for People Living With HIV/AIDS
A study testing Bupropion, Brief Counseling and High-magnitude prize contingency management in people with HIV and AIDS, run by Wayne State University at 1 site in United States.
Trial summary
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV, AIDS, Nicotine Dependence
- What is being tested?
- Bupropion, Brief Counseling and High-magnitude prize contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to read and understand English
- Smoke more than 10 cigarettes/day
- Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
Who cannot join
- Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
- Are in recovery for pathological gambling (PG)
- 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)
- Are already participating in other smoking cessation interventions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
Official title: Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).
- Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
- 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.
- 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.
Read the detailed description
All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.
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
- HIV, AIDS, Nicotine Dependence
- Being tested
- Bupropion, Brief Counseling, High-magnitude prize contingency management, Monitored support to quit smoking, No additional treatment
- Keywords
- HIV, AIDS, Nicotine Dependence, Smoking, Smoking cessation, Contingency Management
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Bupropion hydrochloride, Wellbutrin, Zyban
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Brief CounselingBehavioural
Participants are provided with brief counseling for smoking cessation.
High-magnitude prize contingency managementBehavioural
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 smokingBehavioural
Brief supportive sessions and monitoring of smoking cessation efforts.
No additional treatmentBehavioural
No additional treatment will be given.
Prize contingency management for abstinenceBehavioural
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 managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Standard of Care (A) | Experimental | Brief counseling and bupropion Receives: Drug: Bupropion; Behavioral: Brief Counseling |
| Phase 1: Standard of Care (B) | Experimental | Brief counseling, bupropion, and brief high-magnitude prize contingency management. Receives: Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: High-magnitude prize contingency management |
| Phase 2a Non-Responders (A) | Experimental | Bupropion, continued counseling, monitored support to quit smoking. Receives: Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: Monitored support to quit smoking |
| Phase 2a: Non-Responders (B) | Experimental | Bupropion, monitored support to quit smoking, prize contingency management for abstinence. Receives: Drug: Bupropion; Behavioral: Monitored support to quit smoking; Behavioral: Prize contingency management for abstinence |
| Phase 2b: Responders (A) | Experimental | Bupropion, no additional treatment. Receives: Drug: Bupropion; Behavioral: No additional treatment |
| Phase 2b: Responders (B) | Experimental | Bupropion, continued monitoring and low intensity prize contingency management. Receives: Drug: Bupropion; Behavioral: Monitored support to quit smoking; Behavioral: Low intensity prize contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Cotinine
Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.
Measured: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Longest Duration of Continuous Abstinence
This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
Measured: Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
Seven-Day Point-Prevalence
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.
Measured: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
Carbon Monoxide Results
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.
Measured: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Ledgerwood, Wayne State University
- Investigators
- David Ledgerwood, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965405
- Sponsor's protocol ID
- 1R01DA034537-01A1
- Other IDs
- 1R01DA034537-01A1
- Status last verified
- Jun 2021
- First submitted
- 8 Oct 2013
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39404754
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
- ClinicalTrials.gov ID
- NCT01965405
- Acronym / sponsor ID
- 1R01DA034537-01A1
- Conditions
- HIV, AIDS, Nicotine Dependence
- Keywords
- HIV, AIDS, Nicotine Dependence, Smoking, Smoking cessation, Contingency Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).
- Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
- 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.
- 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.
Detailed description
All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Standard of Care (A) | Experimental | Drug: Bupropion, Behavioral: Brief CounselingBrief counseling and bupropion |
| Phase 1: Standard of Care (B) | Experimental | Drug: Bupropion, Behavioral: Brief Counseling, Behavioral: High-magnitude prize contingency managementBrief counseling, bupropion, and brief high-magnitude prize contingency management. |
| Phase 2a Non-Responders (A) | Experimental | Drug: Bupropion, Behavioral: Brief Counseling, Behavioral: Monitored support to quit smokingBupropion, continued counseling, monitored support to quit smoking. |
| Phase 2a: Non-Responders (B) | Experimental | Drug: Bupropion, Behavioral: Monitored support to quit smoking, Behavioral: Prize contingency management for abstinenceBupropion, monitored support to quit smoking, prize contingency management for abstinence. |
| Phase 2b: Responders (A) | Experimental | Drug: Bupropion, Behavioral: No additional treatmentBupropion, no additional treatment. |
| Phase 2b: Responders (B) | Experimental | Drug: Bupropion, Behavioral: Monitored support to quit smoking, Behavioral: Low intensity prize contingency managementBupropion, continued monitoring and low intensity prize contingency management. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Able to read and understand English
- Smoke more than 10 cigarettes/day
- Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
Key exclusion criteria (4 listed)
- Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
- Are in recovery for pathological gambling (PG)
- 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)
- Are already participating in other smoking cessation interventions.
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 |
|---|---|---|
| BupropionAlso: Bupropion hydrochloride, Wellbutrin, ZybanParticipant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist. | Drug | Phase 1: Standard of Care (A), Phase 1: Standard of Care (B), Phase 2a Non-Responders (A), Phase 2a: Non-Responders (B), Phase 2b: Responders (A), Phase 2b: Responders (B) |
| Brief CounselingParticipants are provided with brief counseling for smoking cessation. | Behavioural | Phase 1: Standard of Care (A), Phase 1: Standard of Care (B), Phase 2a Non-Responders (A) |
| High-magnitude prize contingency managementPrize 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. | Behavioural | Phase 1: Standard of Care (B) |
| Monitored support to quit smokingBrief supportive sessions and monitoring of smoking cessation efforts. | Behavioural | Phase 2a Non-Responders (A), Phase 2a: Non-Responders (B), Phase 2b: Responders (B) |
| No additional treatmentNo additional treatment will be given. | Behavioural | Phase 2b: Responders (A) |
| Prize contingency management for abstinencePrize 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. | Behavioural | Phase 2a: Non-Responders (B) |
| Low intensity prize contingency managementPrize 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. | Behavioural | Phase 2b: Responders (B) |
Primary outcome
Urinary Cotinine
Time frame: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.
Longest Duration of Continuous Abstinence
Time frame: Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
Seven-Day Point-Prevalence
Time frame: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.
Carbon Monoxide Results
Time frame: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 39404754Ledgerwood 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.
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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.
David Ledgerwood, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion, Brief Counseling and High-magnitude prize contingency management in people with HIV and AIDS, run by Wayne State University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Urinary Cotinine (time frame: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)). The study lists 4 primary outcomes in all. 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 NCT01965405, which also lists 1 linked publication.
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 Jul 2021.