A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
- Conditions
- Tobacco Use Cessation
- Interventions
- Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhalerDrug: Varenicline or bupropionBehavioral: Contingency Management
- Registration Number
- NCT04490057
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 12 wks NRT/ 12 wks VAR or bupropion Varenicline or bupropion Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks. 12 wks NRT+CM / 12 wks NRT+CM Contingency Management Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks. 12 wks NRT/ 12 wks VAR or bupropion Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks. 12 wks NRT+CM/12 wks NRT+CM plus Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks. 12 wks NRT+CM / 12 wks NRT+CM Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks. 12 wks NRT+CM/ 12 wks VAR or bupropion+CM Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks. 12 wks NRT+CM/ 12 wks VAR or bupropion+CM Varenicline or bupropion Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks. 12 wks NRT/ 12 wks NRT+CM Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks. 12 wks NRT+CM/ 12 wks VAR or bupropion+CM Contingency Management Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks. 12 wks NRT+CM/12 wks NRT+CM plus Contingency Management Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks. 12 wks NRT/ 12 wks NRT Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy. 12 wks NRT/ 12 wks NRT+CM Contingency Management Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.
- Primary Outcome Measures
Name Time Method Self reported reduction in average cigarettes smoked per day at 24 weeks 24 weeks from baseline Self reported reduction in average cigarettes smoked per day
Self reported reduction in average cigarettes smoked per day at 12 weeks 12 weeks from baseline Self reported reduction in average cigarettes smoked per day
- Secondary Outcome Measures
Name Time Method CD4 Count 24 weeks from baseline Median CD4 count adjusting for baseline
eCO confirmed smoking abstinence at 12 weeks 12 weeks from baseline smoking abstinence confirmed by exhaled carbon monoxide
VACS index 2.0 24 weeks from baseline A validated measure of morbidity and mortality
HIV Viral Load 24 weeks from baseline The proportion of participants with HIV viral load suppression.
eCO confirmed smoking abstinence at 24 weeks 24 weeks from baseline smoking abstinence confirmed by exhaled carbon monoxide
Trial Locations
- Locations (4)
SUNY Downstate STAR Clinic
🇺🇸Brooklyn, New York, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Bridgeport Hospital Infectious Disease Clinic
🇺🇸Bridgeport, Connecticut, United States