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

Last updated: January 7, 2025
Sponsor: Yale University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Tobacco Use Disorder

Treatment

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

Varenicline or bupropion

Contingency Management

Clinical Study ID

NCT04490057
2000026332
R01CA243910
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV positive;

  • >= 18 years old

  • Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount SinaiHospital, 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

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).

Study Design

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Phase: 4
Study Start date:
July 27, 2020
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Bridgeport Hospital Infectious Disease Clinic

    Bridgeport, Connecticut 06110
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • SUNY Downstate STAR Clinic

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

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