Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

NCT02460900 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: HP-00062925R01HL136253
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

The single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIV/AIDS who smoke to quit. The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit smoking.

Conditions

Smoking; HIV

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks

  7-day point-prevalence abstinence based onno self-reported tobacco use (not even a puff) during the 7 days preceding the assessment and a CO ≤10ppm as measured by Covita micro smokrlyzer at week 36.

  36 weeks

Other Outcomes (1)

• Biomarker Evaluation

  36 weeks

Study Arms (4)

Varenicline and Standard of Care

ACTIVE COMPARATOR

Participants will receive varenicline and standard of care

Drug: Varenicline; Behavioral: Standard of Care

Placebo and Standard of Care

PLACEBO COMPARATOR

Participants will receive placebo and standard of care

Drug: Placebo; Behavioral: Standard of Care

Positively Smoke Free and Placebo

ACTIVE COMPARATOR

Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo

Behavioral: Positively Smoke Free; Drug: Placebo

Positively Smoke Free and Varenicline

ACTIVE COMPARATOR

Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline

Drug: Varenicline; Behavioral: Positively Smoke Free

Interventions

Varenicline DRUG

Positively Smoke Free and Varenicline; Varenicline and Standard of Care

Positively Smoke Free BEHAVIORAL

Positively Smoke Free and Placebo; Positively Smoke Free and Varenicline

Placebo DRUG

Placebo and Standard of Care; Positively Smoke Free and Placebo

Standard of Care BEHAVIORAL

Placebo and Standard of Care; Varenicline and Standard of Care

Eligibility Criteria

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

You may qualify if:

• Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic.
• Age 18 years or older.
• Currently self-report smoking 10 cigarettes per day
• Motivation to quit within the next 6 months (score 5-8 on the Abrams and Briener Readiness to Quit Ladder);
• Does not meet criteria for current Diagnostic Statistical Manual (DSM) 5 moderate or severe alcohol use disorder or moderate or severe substance use disorder as established by the Mini Neuropsychiatric Interview (MINI) drug and alcohol sections (in the last 3 months)
• Able to read and speak English
• Willingness and ability to provide informed consent to participate.

You may not qualify if:

• Current suicidal thoughts or ideation (past week); recent suicidal thoughts or ideation (past 6 months) or recent suicide attempt (past 6 months) as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Previous allergic reaction or hypersensitivity to Varenicline (by participant report ever in lifetime)
• Pregnant, nursing, or becoming pregnant during the study (pregnancy test).
• Current use of any medication that would interfere with the protocol in the opinion of Medically Accountable Physician including use of bupropion targeting nicotine dependence
• Moderate to severe renal impairment (\< 30 mL/min)--As determined by a physician assessment, chart review or thru blood work
• Unstable cardiovascular disease (myocardial infarction within past year, uncontrolled arrhythmia, uncontrolled angina, uncontrolled congestive heart failure, electrocardiogram abnormality with QTC \> 500 msec, cerebrovascular event within past year). (As determined by a physician assessment, chart review and/or EKG)
• Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale. This criterion is included to ensure the sample consists of participants who are cognitively able to engage in the study procedures
• Scores \<5 ppm of expired carbon monoxide (CO) on the Smokelyzer
• Recent use of Varenicline (by participant report in the past 3 months)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Maryland Medical Center, Midtown Campus

Baltimore, Maryland, 21210, United States

Location

Related Publications (1)

• Omanya AA, Shuter J, Koech E, Ojoo S, Potts W, Li L, Kahler CW, Himelhoch SS. Mediation Effects of Biobehavioral Factors in a Trial of Pharmacotherapy and Intensive Cessation Counseling for People with HIV Who Smoke Cigarettes in Nairobi, Kenya. AIDS Behav. 2025 Dec 10. doi: 10.1007/s10461-025-04968-5. Online ahead of print.

  PMID: 41369963 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Varenicline; Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

From March 16, 2020-August 10, 2020 study recruitment was halted due to COVID-19.

Results Point of Contact

• Title: National Heart, Lung and Blood Institute--Josh Fessel
• Organization: NIH

josh.fessel@nih.gov

3018275514

Study Officials

• Seth Himelhoch, MD, MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Deanna Kelly, PharmD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 3, 2015
• Study Start: July 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 13, 2025
• Results First Posted: March 7, 2023

Record last verified: 2025-02

Locations

US (1)