Boston, Massachusetts 02114

  • Nicotine Dependence

Purpose:

Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).


Study summary:

Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations. In fact, the initiation and maintenance of smoking is twice as likely for individuals living with HIV than individuals not living with HIV. Smokers living with HIV represent a major health disparity population in the United States (US) and the world more generally, and their unique healthcare needs are not being adequately addressed. For people living with HIV, smoking is related to poorer survival, and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV. A major contributing factor to the maintenance and relapse of smoking among smokers living with HIV is the increased exposure to multiple stressors associated with HIV (e.g., compromised health status, stigma, cognitive impairment), which in turn, contributes to heightened anxiety/depression. Further, smokers living with HIV tend to rely on smoking to regulate their negative mood. As a result, smokers living with HIV require specialty care options that address their unique 'affective needs.' The proposed intervention is informed by the success of a recently completed research project (NCT01393301) in which the feasibility and acceptability of a 9-session, cognitive-behavioral therapy-based intervention to address smoking cessation and symptoms of anxiety and depression by targeting common processes underlying anxiety/depression (distress intolerance, anxiety sensitivity, anhedonia) was tested in a pilot randomized controlled trial (RCT) against an enhanced treatment as usual condition. Investigators named this intervention "QUIT". In the pilot RCT, smoking abstinence was significantly higher in the intervention than in the standard of care control at both the 1-month follow-up (the end-of-treatment timepoint) and the 6-month follow-up, and anxiety and depressive symptom severity was lower in the intervention condition than the control condition at the same timepoints. The present study seeks to conduct a fully powered, 3-arm hybrid efficacy/effectiveness trial, integrating resource utilization and cost-effectiveness analyses. The investigators propose to randomize 180 smokers living with HIV across three implementation sites. Two-fifths of the sample (n = 72) will be randomized to the QUIT intervention; two-fifths (n = 72) to an active, credible time-matched control (TM) and one-fifth (n = 36) to a standard-of-care (SOC) control. The primary outcomes of this study will be point prevalence abstinence at the 1-Month Follow-Up (end of treatment timepoint/ approximately 1-month post quit day) and 6-Month Follow-Up (approximately 6-months post quit day). Changes in anxiety/depressive symptom severity will also be examined, and cost-effectiveness analyses will be conducted.


Criteria:

Inclusion Criteria: - 18-79 years old - Daily Smoker - Motivated to quit smoking - HIV-positive - Capability and willingness to give written informed consent Exclusion Criteria: - Habitual use of tobacco products other than cigarettes - Untreated or unstable psychiatric disorders - Current smoking cessation treatment - Cognitive behavioral therapy for anxiety within the past year - Insufficient command of the English language


NCT ID:

NCT03904186


Primary Contact:

Principal Investigator
Jasper Smits, PhD
University of Texas at Austin

Conall M O'Cleirigh, PhD
Phone: 617-643-0385
Email: cocleirigh@mgh.harvard.edu


Backup Contact:

Email: smarquez1@mgh.harvard.edu
Samantha M McKetchnie, MSW
Phone: 617-724-9944


Location Contact:

Boston, Massachusetts 02114
United States

Samantha M McKetchnie, MSW
Phone: 617-643-0385
Email: smarquez1@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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