NCT04725617

Wellness Intervention for Smoking and HIV

Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions \[weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13\]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

Detailed description

Cigarette smoking among adults living with HIV (ALHIV) is a significant public health problem, leading to substantial morbidity and mortality in this population. Existing smoking cessation interventions are not sufficient, as success rates are relatively low. Poor sleep is more prevalent among smokers, more prevalent among ALHIV, can be caused by smoking cessation attempts, predicts relapse to former smoking patterns, and represents a parallel pathway to morbidity including increased cardiovascular disease (CVD) among ALHIV. Thus, unhealthy sleep may make smoking cessation more difficult and increase cardiovascular risk and other poor health conditions in ALHIV. The proposed study will supplement an empirically-supported smoking cessation program (8-session, 13-week counseling program with varenicline tartrate) with a pre-determined behavioral health approach to reducing smoking intervention developed for smokers. The investigators will test the efficacy of behavioral health approach 1 versus behavioral health approach 2 as an active comparator. The investigators will also explore the impact of smoking cessation and changes in sleep on changes in inflammatory biomarkers of cardiovascular disease risk. Approximately 400 ALHIV treatment seeking smokers who have no history of sleep disorders will be screened (through history, physical examination, laboratory studies and an overnight sleep test) to identify 200 eligible subjects to randomize to Intervention Approach 1 versus Intervention Approach 2. All participants will concurrently receive standard smoking cessation treatment including counseling and 12-weeks of varenicline tartrate. Screening and treatment sessions will take place at the University of Arizona's Clinical and Translational Sciences Research Center, which is well equipped with private examination rooms and phlebotomists. Successful smoking cessation will be assessed at end of therapy (13 weeks) and again 6 months later by self reports, carbon monoxide breath test, and urine and serum cotinine, a stringent objective marker of tobacco use. Sleep will be assessed through sleep diaries, questionnaires and actigraphy (activity sensors worn on the wrist). Other markers of CVD risk including lipids, 24 hour blood pressure monitoring, and HgbA1C, and biomarkers (IL-6, hsCRP, TNFalpha,ICAM-1, VCAM-1, sCD14, D-dimer) will be determined at baseline, end of therapy, and 6 months follow up. Cognitive function will be assessed through N-Back (uses images), Psychomotor Vigilance Test (PVT), Abstract Matching (AM), Digital Symbol Substitution Task (DSST), Visual Object Learning Task (VOLT), Motor Praxis Task (MPT), Balloon Analog Risk Task (BART), and Line Orientation Task (LOT). Ultimately, the impact of this work will be to transform clinical guidelines for the treatment of nicotine dependence, as well as to provide insights into mechanisms by which improved sleep enhances tobacco cessation.

Conditions

• HIV
• Sleep
• Smoking Cessation
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Varenicline	Standard smoking cessation treatment.
BEHAVIORAL	Smoking Cessation Counseling	Standard smoking cessation treatment
BEHAVIORAL	Health Approach 1 to Reduce Smoking	Behavioral health intervention option 1
OTHER	Health Approach 2 to Reduce Smoking	Behavioral health intervention option 2

Timeline

• Start date: 2021-11-16
• Primary completion: 2025-09-28
• Completion: 2025-09-28
• First posted: 2021-01-27
• Last updated: 2025-08-19

Locations

2 sites across 1 country: United States