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Pharmacogenetic and Adherence Optimization Treatments for the Improvement of Smoking Cessation in Smokers with HIV
Trial Status: active
This phase III trial compares the standard smoking cessation treatment with the pharmacogenetic and adherence optimized intervention in reducing smoking in smokers with human immunodeficiency virus (HIV) infection. This study is to determine the benefits of an individualized treatment approach, compared to a non-personalized treatment approach and to test Managed Problem Solving intervention as a way to increase adherence to treatment.
Inclusion Criteria
Over the age of 18
Smoke daily for the past 30 days
Have a confirmed diagnosis of human immunodeficiency virus (HIV)
Be able to communicate in English
Be able to provide informed consent
Agree to live in the geographic area close to one of the sites for at least 7 months
Be able to use varenicline or TN patch safely (e.g., no past allergic reaction to varenicline or nicotine patch)
Exhibit viral load of < 1000 copies/mL (to ensure ability to meet the trial demands)
Exclusion Criteria
Current untreated and unstable diagnosis of substance abuse or dependence (if past abuse and if receiving treatment or stable for >= 30 days, eligible with clinician approval)
Current use or discontinuation within last 14 days of quit smoking medications. Past or current use of corticosteroids for treatment of asthma (or any other condition) requires study physician approval
Women who are pregnant, planning a pregnancy, or lactating
Current diagnosis of unstable and untreated major depression or bipolar disorder (if stable for > 30 days, eligible with clinician approval)
Diagnosed with psychotic disorder
Cancer, heart disease, stroke or MI within the past 6 months
Latex allergy or past allergic reaction to adhesive tape
History of diabetes or stomach ulcers requires study physician approval
Uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)
History of epilepsy or seizure disorder
History of kidney or liver failure
Suicide risk as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Use of e-cigarettes, chewing tobacco, snuff or snus
Currently participating in a smoking cessation program
Additional locations may be listed on ClinicalTrials.gov for NCT04176172.
I. To examine the effects of the nicotine metabolite ratio (NMR)-tailored and Managed Problem Solving (MAPS) interventions on end-of-treatment (EOT) and 6-month smoking cessation rates.
SECONDARY OBJECTIVES:
I. To examine mediators of the NMR-tailored and MAPS interventions.
II. To examine moderators of the NMR-tailored and MAPS interventions.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I (STANDARD TREATMENT ARM): Participants receive varenicline orally (PO) once daily (QD) on days 1-3, PO twice daily (BID) on days 4-84. Participants also receive standard behavioral counseling and adherence advice at weeks 1, 2, 4, 6, and 8.
ARM II (PHARMACOGENETIC OPTIMIZATION ARM): Participants receive NMR-personalized medication treatment (varenicline for fast metabolizers and transdermal nicotine [TN] patches for slow metabolizers) for 12 weeks. Participants also receive standard behavioral counseling and adherence advice at weeks 1, 2, 4, 6, and 8.
ARM III (ADHERENCE OPTIMIZATION ARM): Participants receive varenicline and standard behavioral counseling as in Arm I. Participants also receive MAPS intervention at weeks 1, 2, 4, 6, and 8.
ARM IV (PHARMACOGENETIC AND ADHERENCE OPTIMIZATION ARM): Participants receive NMR-personalized medication treatment (varenicline for fast metabolizers and TN patches for slow metabolizers) for 12 weeks. and standard behavioral counseling and adherence advice at weeks 1, 2, 4, 6, and 8. Participants also receive MAPS intervention at weeks 1, 2, 4, 6, and 8.
After completion of study, participants are followed up at 12 and 26 weeks.
Trial PhasePhase III
Trial Typeprevention
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
