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

Tobacco Use Cessation Clinical Trial

— SMARTTT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04490057
• Other study ID #: 2000026332
• Secondary ID: R01CA243910
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 27, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 outcome will be self-reported abstinence at 24 weeks post-enrollment (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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: September 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
• Varenicline or bupropion
Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).

Behavioral:
• Contingency Management
Participants will be financially rewarded for abstinence to tobacco.

Locations

Country	Name	City	State
United States	Bridgeport Hospital Infectious Disease Clinic	Bridgeport	Connecticut
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identification of Barriers and Facilitators	Using a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.	Baseline and Up to 4 years
Primary	Self reported reduction in average cigarettes smoked per day at 24 weeks	Self reported reduction in average cigarettes smoked per day	24 weeks from baseline
Primary	Self reported reduction in average cigarettes smoked per day at 12 weeks	Self reported reduction in average cigarettes smoked per day	12 weeks from baseline
Secondary	VACS index 2.0	A validated measure of morbidity and mortality	24 weeks from baseline
Secondary	CD4 Count	Median CD4 count adjusting for baseline	24 weeks from baseline
Secondary	HIV Viral Load	The proportion of participants with HIV viral load suppression.	24 weeks from baseline
Secondary	eCO confirmed smoking abstinence at 24 weeks	smoking abstinence confirmed by exhaled carbon monoxide	24 weeks from baseline
Secondary	eCO confirmed smoking abstinence at 12 weeks	smoking abstinence confirmed by exhaled carbon monoxide	12 weeks from baseline