Testing Integrative Smoking Cessation for HIV Patients

HIV Infections Clinical Trial

Official title:

A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030766
• Other study ID #: 20201296
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2022
• Est. completion date: June 3, 2024

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: Taghrid Asfar, MD, MSPH
• Phone: 3052433826
• Email: tasfar[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 3, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with HIV (based on self-report).
• Be 18 years and older
• Have smoked = 5 cigarettes/day in the past year
• Be interested in making a quit attempt in the next 30 days
• Own a smartphone (apple/android), and plan to keep it active for the next 6 months
• Able to consent
• Have no plans to move in the next 6 months
• Are not pregnant or planning to be pregnant in the following 6 months
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Exclusion Criteria:

• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Are currently being treated for a psychiatric condition.
• Are currently being treated for smoking cessation, alcoholism, or illicit drug use
• Are adults unable to consent
• Are individuals who are not yet adults
• Are pregnant women
• Are prisoners

Related Conditions & MeSH terms

• HIV Infections
• Smoking
• Smoking Cessation

Intervention

Drug:
• Nicotine Replacement Therapy
6 weeks of Nicotine replacement patches

Behavioral:
• Mindfulness Training Smoking Cessation Intervention
Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.
• Contingency Management Smoking Cessation Intervention
Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting 7-day point-prevalence abstinence	Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level of < 6 ppm.	Up to 22 weeks
Secondary	Number of enrolled participants	Study feasibility will be reported as the number of participants that were screened and enrolled per month	Baseline
Secondary	Average enrollment time	Study feasibility will be reported as the average time to enroll participants to form classes	Baseline
Secondary	Retention rate	Treatment specific retention rates will be reported as the number of participants completing all study procedures dived by the total of participants enrolled.	Up to 22 weeks
Secondary	Number of completed study measures	Defined as number of in-person session attended, and number of homework assignments completed.	Up to 22 weeks