SMARTTT: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 632 adult PWH who smoke cigarettes and receive care in one of three health systems. 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]) 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 outcome will be eCO-confirmed abstinence at 24 weeks post-enrollment. The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote eCO-confirmed smoking abstinence (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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 12 wks NRT+CM / 12 wks NRT+CM Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks. |
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.
|
| Experimental: 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. |
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
Particpants will be financially rewarded for abstinence to tobacco.
|
| Experimental: 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. |
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.
|
| Experimental: 12 wks NRT/ 12 wks NRT Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy. |
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
|
| Experimental: 12 wks NRT/ 12 wks VAR or bupropion Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks. |
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).
|
| Experimental: 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. |
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.
|
Outcome Measures
Primary Outcome Measures
- eCO confirmed abstinence at 24 weeks [24 weeks from baseline]
Abstinence from tobacco confirmed by exhaled carbon monoxide
Secondary Outcome Measures
- VACS index 2.0 [24 weeks from baseline]
A validated measure of morbidity and mortality
- CD4 Count [24 weeks from baseline]
Median CD4 count adjusting for baseline
- HIV Viral Load [24 weeks from baseline]
The proportion of participants with HIV viral load suppression.
Other Outcome Measures
- Identification of Barriers and Facilitators [Baseline and Up to 4 years]
Using a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV positive;
-
= 18 years old
-
Receiving HIV care at Yale-New Haven 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);
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Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
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Life-threatening or unstable medical, surgical, or psychiatric condition;
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Inability to provide at least one collateral contact (family member or friend);
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Living out of state;
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Unable to read or understand English (except at Mount Sinai site).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 2 | SUNY Downstate STAR Clinic | Brooklyn | New York | United States | 11203 |
| 3 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Yale University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: E. Jennifer Edelman, MD, MHS, Yale University
- Principal Investigator: Steven Bernstein, MD, Yale University
Study Documents (Full-Text)
More Information
Publications
None provided.- 2000026332
- R01CA243910