Optimizing Tobacco Use Treatment for PLWHA

NCT04176172 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 8343451R01CA243914-01
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

The advent of anti-retroviral therapy (ART) for people living with HIV/AIDS (PLWHA) substantially improved life expectancy but has also led to the critical need to address modifiable risk factors associated with cancer and cardiovascular disease, such as tobacco smoking. HIV-infected smokers lose more life-years due to tobacco use than they do to their HIV infection. There have been relatively few studies of tobacco use treatments for PLWHA and systematic reviews show that there are insufficient data to conclude that tobacco dependence interventions that are efficacious in the general population are efficacious for PLWHA. Further, many studies in this area have lacked randomization and a control group, infrequently used an intent-to-treat (ITT) approach and biological verification of tobacco abstinence, and lacked post-treatment follow-up.10 What investigators do know thus far is that behavioral interventions and the nicotine patch yield moderate effects on cessation; and 2 recent placebo-controlled trials - one in France and one by this lab - found that varenicline is safe and effective for treating tobacco use among PLWHA, but yield quit rates that are substantially lower than those reported in the general population. Thus, there is a critical need to rigorously test novel ways to optimize tobacco cessation treatment for smokers with HIV.

Conditions

HIV/AIDS; Nicotine Dependence

Keywords

Smoking Cessation; Nicotine Dependence; HIV/AIDS; Varenicline; Nicotine Patch; Cigarette Smoking; Managed Problem Solving

Outcome Measures

Primary Outcomes (1)

• Point-prevalence abstinence

  Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for \>7 days prior to week 26 (24 weeks post target quit date) and have an expired carbon monoxide reading of ≤8 parts per million at week 26.

  26 weeks (24 weeks post target quit date)

Secondary Outcomes (4)

• Six-month quit rate

  6 months

• Prolonged abstinence

  26 weeks (24 weeks post target quit date)

• Continuous abstinence

  26 weeks (24 weeks post target quit date)

• Time to 7-day relapse

  26 weeks (24 weeks post target quit date)

Study Arms (2)

Varenicline & Standard Cessation Counseling

ACTIVE COMPARATOR

varenicline plus standard behavioral smoking cessation treatment

Drug: Varenicline; Behavioral: Standard treatment

NMR-Tailored Medication & Standard Cessation Counseling + MAPS

EXPERIMENTAL

varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention

Drug: Varenicline; Drug: Nicotine patch; Behavioral: Standard treatment + Managed Problem Solving (MAPS) adherence intervention

Interventions

Varenicline DRUG

Participants will receive open-label varenicline for 12 weeks.

Also known as: Chantix or Apo-Varenicline

NMR-Tailored Medication & Standard Cessation Counseling + MAPS; Varenicline & Standard Cessation Counseling

Nicotine patch DRUG

Participants will receive open-label nicotine patch for 12 weeks. (Participants in the NMR-tailored treatment arms will receive either varenicline OR patch; they will not receive both)

Also known as: NicoDerm

NMR-Tailored Medication & Standard Cessation Counseling + MAPS

Standard treatment + Managed Problem Solving (MAPS) adherence intervention BEHAVIORAL

Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Managed Problem Solving (MAPS) is a therapeutic process that involves the systematic delineation of a participant's medication adherence problems and construction of a series of individualized solutions that therapists and participants explore together. Participants will receive up to 5 therapy sessions (2 in person, 3 over the phone) over 8 weeks. The first session will directly address potential medication adherence barriers, and therapist and participant will collaboratively brainstorm ways to overcome these barriers.

Also known as: Standard treatment + MAPS

NMR-Tailored Medication & Standard Cessation Counseling + MAPS

Standard treatment BEHAVIORAL

Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Participants will receive up to 5 therapy sessions (2 in person, 3 over the phone) over 8 weeks.

Also known as: Standard Therapy

Varenicline & Standard Cessation Counseling

Eligibility Criteria

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

You may qualify if:

• \>18 years, smoke daily for the past 30 days
• Confirmed HIV+ (exhibit viral load of \<1000 copies/mL)
• Residing in the geographic area close to one of the sites for at least 7 months
• Able to use varenicline/TN patch safely

You may not qualify if:

• Current untreated and unstable diagnosis of substance abuse/dependence
• Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder
• Suicide risk as measured by the C-SSRS
• Current use or discontinuation within last 14 days of quit smoking medications
• Cancer, heart disease, stroke or MI within the past 6 months requires study physician approval
• Uncontrolled hypertension
• History of epilepsy or seizure disorder requires study physician approval
• Women who are pregnant, planning a pregnancy, or lactating
• Use of e-cigarettes, chewing tobacco, snuff or snus
• Generalized eczema or psoriasis
• A reaction or sensitivity to a nicotine patch or any other transdermal medication requires study physician approval
• Currently participating in a smoking cessation program

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Cancer Institute (NCI): collaborator
• Northwestern University: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tobacco Use Disorder; Smoking Cessation; Cigarette Smoking

Interventions

Varenicline; Tobacco Use Cessation Devices; Nicotine; Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics; Solanaceous Alkaloids; Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Schnoll, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Center for Interdisciplinary Research on Nicotine

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: February 17, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

US (2)