Smoking Cessation for People Living With HIV/AIDS

Not Applicable

• Conditions: HIV; AIDS; Nicotine Dependence
• Interventions: Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: Monitored support to quit smoking; Behavioral: No additional treatment; Behavioral: High-magnitude prize contingency management; Behavioral: Prize contingency management for abstinence; Behavioral: Low intensity prize contingency management

• Registration Number: NCT01965405
• Lead Sponsor: Wayne State University

Brief 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 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).

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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Age 18 years or older
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

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Exclusion Criteria

1. Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1: Standard of Care (B)	Brief Counseling	Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Phase 2a: Non-Responders (B)	Monitored support to quit smoking	Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Phase 1: Standard of Care (B)	High-magnitude prize contingency management	Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Phase 2a Non-Responders (A)	Brief Counseling	Bupropion, continued counseling, monitored support to quit smoking.
Phase 2a: Non-Responders (B)	Prize contingency management for abstinence	Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Phase 1: Standard of Care (A)	Brief Counseling	Brief counseling and bupropion
Phase 2b: Responders (B)	Monitored support to quit smoking	Bupropion, continued monitoring and low intensity prize contingency management.
Phase 2a Non-Responders (A)	Monitored support to quit smoking	Bupropion, continued counseling, monitored support to quit smoking.
Phase 2b: Responders (A)	No additional treatment	Bupropion, no additional treatment.
Phase 2b: Responders (B)	Low intensity prize contingency management	Bupropion, continued monitoring and low intensity prize contingency management.
Phase 1: Standard of Care (A)	Bupropion	Brief counseling and bupropion
Phase 1: Standard of Care (B)	Bupropion	Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Phase 2a Non-Responders (A)	Bupropion	Bupropion, continued counseling, monitored support to quit smoking.
Phase 2a: Non-Responders (B)	Bupropion	Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Phase 2b: Responders (A)	Bupropion	Bupropion, no additional treatment.
Phase 2b: Responders (B)	Bupropion	Bupropion, continued monitoring and low intensity prize contingency management.

Primary Outcome Measures

Name	Time	Method
Urinary Cotinine	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	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	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	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.

Trial Locations

Locations (1)

Tolan Park Medical Building; 🇺🇸 Detroit, Michigan, United States