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Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

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ClinicalTrials.gov Identifier: NCT02460900
Recruitment Status : Recruiting
First Posted : June 3, 2015
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Smoking HIV Drug: Varenicline Behavioral: Positively Smoke Free Drug: Placebo Behavioral: Standard of Care Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Smoking
Drug Information available for: Varenicline

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 7-day point prevalence abstinence [ Time Frame: 24 weeks ]
    This represents a 7 day period of abstinence from cigarette smoking at any point during the 24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460900


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

Locations
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United States, Maryland
University of Maryland Medical Center, Midtown Campus Recruiting
Baltimore, Maryland, United States, 21210
Contact: Wendy Potts, MS    410-706-2490    wpotts@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: Seth Himelhoch, MD, MPH University of Maryland
Principal Investigator: Deanna Kelly, PharmD University of Maryland

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Responsible Party: Deanna Kelly, Professor of Psychiatry, University of Maryland
ClinicalTrials.gov Identifier: NCT02460900     History of Changes
Other Study ID Numbers: HP-00062925
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs