Phase 4
N=323
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Tobacco Use Cessation
Bottom Line
View on ClinicalTrials.gov: NCT04490057 ↗Enrolled (actual)
323
Serious AEs
6.1%
Results posted
Nov 2025
Primary outcome: Primary: Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks — 5.2; 4.9 cigarettes per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler (Drug); Varenicline or bupropion (Drug); Contingency Management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks |
5.2; 4.9 | — |
| PRIMARY Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks |
7.90; 6.23; 2.97; 10.92; 4.00; 4.20 | — |
| SECONDARY Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks |
16; 36 | — |
| SECONDARY Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks |
4; 6; 7; 23; 3; 8 | — |
| SECONDARY VACS Index 2.0 Score |
42.88; 47.26; 49.42; 42.65; 42.66; 43.63 | — |
| SECONDARY CD4 Count |
668.00; 576.53; 648.38; 640.57; 724.92; 696.97 | — |
| SECONDARY HIV Viral Load, Detectable |
0; 10; 14; 3; 5; 7 | — |
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 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).
Data sourced from ClinicalTrials.gov (NCT04490057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.