Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Study

Exclusion Criteria

The exclusion criteria are designed to maximize safety by minimizing drug interactions or worsening pre-existing comorbid psychiatric or medical conditions:

1. 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).

2. Previous allergic reaction or hypersensitivity to Varenicline (by participant report ever in lifetime)

3. Pregnant, nursing, or becoming pregnant during the study (pregnancy test).

4. 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

5. Moderate to severe renal impairment (< 30 mL/min)--As determined by a physician assessment, chart review or thru blood work

6. 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)

7. 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

8. Scores <5 ppm of expired carbon monoxide (CO) on the Smokelyzer

9. The study physician believes that the individual is not medially stable enough to participate in the study. This exclusion will be based on a review of the individual's past medical history and current medical status.

10. Recent use of Varenicline (by participant report in the past 3 months)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Varenicline and Standard of Care
Participants will receive varenicline and standard of care
  • Drug: Varenicline
  • Behavioral: Standard of Care
Placebo Comparator
Placebo and Standard of Care
Participants will receive placebo and standard of care
  • Drug: Placebo
  • Behavioral: Standard of Care
Active Comparator
Positively Smoke Free and Placebo
Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo
  • Behavioral: Positively Smoke Free
  • Drug: Placebo
Active Comparator
Positively Smoke Free and Varenicline
Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline
  • Drug: Varenicline
  • Behavioral: Positively Smoke Free

Recruiting Locations

University of Maryland Medical Center, Midtown Campus
Baltimore, Maryland 21210
Contact:
Wendy Potts, MS
410-706-2490
wpotts@som.umaryland.edu

More Details

NCT ID
NCT02460900
Status
Recruiting
Sponsor
University of Maryland, College Park

Study Contact

Wendy S Potts, MS
(410) 706-2490
wpotts@som.umaryland.edu

Detailed Description

The investigators propose a factorial design strategy to evaluate the effects, individually and in combination, of the most promising pharmaco- and behavioral cessation therapies available for PLWH according to the review of the extant literature for HIV-infected and general population smokers. The sizable cohort and prospective design will also permit the investigators to evaluate the effects of tobacco use, treatment, and cessation on a panel of soluble biomarkers of inflammation that are likely contributors to cardiac morbidity and mortality in people living with HIV/AIDS. The specific aims of the study are:

Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence (PPA) at 24 weeks in smokers with HIV/AIDS. It is hypothesized that rates of smoking abstinence at week 24 will be higher in those treated with varenicline compared to placebo.

Primary Aim 2: Compare Positively Smoke Free to low intensity, brief counseling on rates of 7-day PPA at 24 weeks in smokers with HIV/AIDS. It is hypothesized that rates of smoking abstinence at week 24 will be higher in those treated with Positively Smoke Free compared to brief counseling.

Secondary Aim: Compare Positively Smoke Free + varenicline to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIV/AIDS at 24 weeks. It is hypothesized that the effect of PSF with varenicline is greater than the effect of PSF or varenicline alone.

Exporatory Aim: Explore the effect of successful cessation/smoking abstinence on levels of cardiac specific biomarkers, nicotine biomarkers, generalized markers of inflammation, lipids, coagulation and monocyte/macrophage activation. The investigators hypothesize that smoking cessation will be associated with significant reductions in levels of these biomarkers and monocyte/macrophage activation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.