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

Yale University

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Cessation

Treatments: Drug: Varenicline or bupropion; Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler; Behavioral: Contingency Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04490057

2000026332

R01CA243910 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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323 participants in 6 patient groups

12 wks NRT+CM / 12 wks NRT+CM

Experimental group

Description:

Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.

Treatment:

Behavioral: Contingency Management

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler

12 wks NRT+CM/ 12 wks VAR or bupropion+CM

Experimental group

Description:

Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.

Treatment:

Behavioral: Contingency Management

Drug: Varenicline or bupropion

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler

12 wks NRT+CM/12 wks NRT+CM plus

Experimental group

Description:

Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.

Treatment:

Behavioral: Contingency Management

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler

12 wks NRT/ 12 wks NRT

Experimental group

Description:

Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.

Treatment:

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler

12 wks NRT/ 12 wks VAR or bupropion

Experimental group

Description:

Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.

Treatment:

Drug: Varenicline or bupropion

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler

12 wks NRT/ 12 wks NRT+CM

Experimental group

Description:

Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.

Treatment:

Behavioral: Contingency Management

Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler