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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2025-10-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing Tobacco Use Treatment for PLWHA

NCT04176172

HIV/AIDS Nicotine Dependence

RECRUITING PHASE3

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

NCT02460900

Smoking HIV

COMPLETED PHASE3

Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts

NCT04994444

Tobacco Use Cessation

COMPLETED PHASE2/PHASE3

Smoking Cessation Using Motivational Therapy and Varenicline

NCT00701896

Smoking HIV Infections

COMPLETED NA

Mobile Health Interventions for Medication Adherence Among PLWH

NCT04191278

HIV/AIDS Smoking Smoking Cessation +1 more

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential multiple assignment randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Varenicline or bupropion

Intervention Type DRUG

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

Contingency Management

Intervention Type BEHAVIORAL

Participants will be financially rewarded for abstinence to tobacco.

12 wks NRT+CM / 12 wks NRT+CM

Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Contingency Management

Intervention Type BEHAVIORAL

Participants will be financially rewarded for abstinence to tobacco.

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Contingency Management

Intervention Type BEHAVIORAL

Participants will be financially rewarded for abstinence to tobacco.

12 wks NRT/ 12 wks NRT

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

12 wks NRT/ 12 wks VAR or bupropion

Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Varenicline or bupropion

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Contingency Management

Intervention Type BEHAVIORAL

Participants will be financially rewarded for abstinence to tobacco.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DRUG

Varenicline or bupropion

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

Intervention Type DRUG

Contingency Management

Participants will be financially rewarded for abstinence to tobacco.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No