Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
The study used a factorial design to randomize participants into 4 conditions: (1) Varenicline (12 weeks) + Positively Smoke Free (PSF) (8 weeks); (2) Varenicline (12 weeks) + Standard of Care (brief advice to quit); (3) Placebo (12 weeks) + Positively Smoke Free (8 weeks); and (4) Placebo (12 weeks) + Standard of Care. The primary outcome was the 7-day point prevalence abstinence (PPA) (<10mm) at 36 weeks.
The specific aims of our proposal are:
Primary Aim 1: Compare varenicline to placebo on rates of 7-day point prevalence abstinence (PPA) at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 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 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling.
Primary Aim 3: 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 36 weeks. We hypothesize 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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21210
- University of Maryland Medical Center, Midtown Campus
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Study Inclusion Criteria:
- 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.
Study Exclusion Criteria:
The exclusion criteria are designed to maximize safety by minimizing drug interactions or worsening pre-existing comorbid psychiatric or medical conditions:
- 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
- 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.
- Recent use of Varenicline (by participant report in the past 3 months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Varenicline and Standard of Care
Participants will receive varenicline and standard of care
|
|
|
Placebo Comparator: Placebo and Standard of Care
Participants will receive placebo and standard of care
|
|
|
Active Comparator: Positively Smoke Free and Placebo
Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Placebo
|
|
|
Active Comparator: Positively Smoke Free and Varenicline
Participant will receive Positively Smoke Free (a tailored behavioral intervention) and Varenicline
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With 7-day Point Prevalence Abstinence at 36 Weeks
Time Frame: 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 Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomarker Evaluation
Time Frame: 36 weeks
|
Effect of smoking abstinence on levels of cardiac specific biomarkers
|
36 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Seth Himelhoch, MD, MPH, University of Maryland, Baltimore
- Principal Investigator: Deanna Kelly, PharmD, University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Agents
- Cholinergic Agents
- Nicotinic Agonists
- Cholinergic Agonists
- Varenicline
Other Study ID Numbers
Other Study ID Numbers
- HP-00062925
- R01HL136253 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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