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

NCT04490057 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2000026332R01CA243910
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 4

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.

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (2)

• Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks

  Self reported reduction in average cigarettes smoked per day at 12 weeks

  Week 12

• Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks

  Self reported reduction in cigarettes smoked per day at 24 weeks

  24 weeks

Secondary Outcomes (5)

• Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks

  12 weeks from baseline

• Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks

  24 weeks from baseline

• VACS Index 2.0 Score

  24 weeks from baseline

• CD4 Count

  24 weeks from baseline

• HIV Viral Load, Detectable

  24 weeks from baseline

Study Arms (6)

12 wks NRT+CM / 12 wks NRT+CM

EXPERIMENTAL

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; Behavioral: Contingency Management

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

EXPERIMENTAL

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; Drug: Varenicline or bupropion; Behavioral: Contingency Management

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

EXPERIMENTAL

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; Behavioral: Contingency Management

12 wks NRT/ 12 wks NRT

EXPERIMENTAL

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

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

12 wks NRT/ 12 wks VAR or bupropion

EXPERIMENTAL

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; Drug: Varenicline or bupropion

12 wks NRT/ 12 wks NRT+CM

EXPERIMENTAL

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; Behavioral: Contingency Management

Interventions

Varenicline or bupropion DRUG

Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).

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

Contingency Management BEHAVIORAL

Participants will be financially rewarded for abstinence to tobacco.

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

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

Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Yale University: lead

Study Sites (4)

Bridgeport Hospital Infectious Disease Clinic

Bridgeport, Connecticut, 06110, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

SUNY Downstate STAR Clinic

Brooklyn, New York, 11203, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• Edelman EJ, Deng Y, Dziura J, Nahum-Shani I, Weiss JM, Aoun-Barakat L, Bold KW, Harsono D, Mistler C, Payne E, Aiudi S, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560593. doi: 10.1001/jamanetworkopen.2025.60593.

  PMID: 41758512 DERIVED

• Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.

  PMID: 33794354 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Nicotine; Varenicline; Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Propiophenones; Ketones; Organic Chemicals

Limitations and Caveats

1\. The COVID-19 pandemic delayed enrollment leading to a reduction in sample size and change in endpoint to reduction in # of cigarettes/day. Due to these changes, we may have been underpowered to detect improved abstinence in Stage 2. 2. Participants were given prescriptions for medication, not actual medication and we observed access issues. 3. The study was conducted in urban HIV clinics in the Northeast US which may limit generalizability.

Results Point of Contact

• Title: E. Jennifer Edelman, MD, MHS
• Organization: Yale University

ejennifer.edelman@yale.edu

203-727-7115

Study Officials

• E. Jennifer Edelman, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

• Steven Bernstein, MD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential multiple assignment randomized trial

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: July 27, 2020
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2025
• Last Updated: January 5, 2026
• Results First Posted: November 28, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)