NCT04490057

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Use Cessation

Interventions

Type	Name	Description
DRUG	Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler	Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
DRUG	Varenicline or bupropion	Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).
BEHAVIORAL	Contingency Management	Participants will be financially rewarded for abstinence to tobacco.

Timeline

• Start date: 2020-07-27
• Primary completion: 2024-10-24
• Completion: 2025-10-24
• First posted: 2020-07-28
• Last updated: 2026-01-05
• Results posted: 2025-11-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study