A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Overview
- Phase
- Phase 4
- Intervention
- Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
- Conditions
- Tobacco Use Cessation
- Sponsor
- Yale University
- Enrollment
- 323
- Locations
- 8
- Primary Endpoint
- Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.
Detailed Description
Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three health systems (targeted enrollment changed from 632 to 320 with NCI approval and IRB protocol amendment). At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide \[eCO\] or collateral verification) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule \["CM plus"\] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcomes will be self-reported reduction in average cigarettes smoked per day at 24 weeks and 12 weeks (primary outcome changed from eCO-confirmed abstinence to self-reported abstinence with NCI approval and IRB protocol amendment). The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote reduced tobacco use (changed from eCO-confirmed smoking abstinence with NCI approval and protocol amendment) (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV positive;
- •\>= 18 years old
- •Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
- •Have smoked \>= 100 cigarettes in lifetime;
- •Currently smokes some days or every day;
- •Smokes, on average, \>= 5 cigarettes per day;
- •Able to provide written informed consent.
Exclusion Criteria
- •Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
- •Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
- •Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- •Life-threatening or unstable medical, surgical, or psychiatric condition;
- •Inability to provide at least one collateral contact (family member or friend);
- •Living out of state;
- •Unable to read or understand English (except at Mount Sinai site).
Arms & Interventions
12 wks NRT+CM / 12 wks NRT+CM
Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT+CM / 12 wks NRT+CM
Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
Intervention: Contingency Management
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
Intervention: Varenicline or bupropion
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
Intervention: Contingency Management
12 wks NRT+CM/12 wks NRT+CM plus
Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT+CM/12 wks NRT+CM plus
Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
Intervention: Contingency Management
12 wks NRT/ 12 wks NRT
Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT/ 12 wks VAR or bupropion
Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT/ 12 wks VAR or bupropion
Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.
Intervention: Varenicline or bupropion
12 wks NRT/ 12 wks NRT+CM
Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.
Intervention: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
12 wks NRT/ 12 wks NRT+CM
Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.
Intervention: Contingency Management
Outcomes
Primary Outcomes
Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
Time Frame: Week 12
Self reported reduction in average cigarettes smoked per day at 12 weeks
Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks
Time Frame: 24 weeks
Self reported reduction in cigarettes smoked per day at 24 weeks
Secondary Outcomes
- Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks(12 weeks from baseline)
- Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks(24 weeks from baseline)
- VACS Index 2.0 Score(24 weeks from baseline)
- CD4 Count(24 weeks from baseline)
- HIV Viral Load, Detectable(24 weeks from baseline)