Testing Integrative Smoking Cessation for HIV Patients

Phase 4

Completed

• Conditions: Smoking; Smoking Cessation; HIV Infections
• Interventions: Drug: Nicotine Replacement Therapy; Behavioral: Mindfulness Training Smoking Cessation Intervention; Behavioral: Contingency Management Smoking Cessation Intervention

• Registration Number: NCT05030766
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-01
• Study Start: 2022-01-04
• Status Verified: 2024-05
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MT plus NRT Group	Mindfulness Training Smoking Cessation Intervention	Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
MT plus NRT Group	Nicotine Replacement Therapy	Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
CM plus NRT Group	Nicotine Replacement Therapy	Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
CM plus NRT Group	Contingency Management Smoking Cessation Intervention	Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
MT plus NRT with additional CM Group	Mindfulness Training Smoking Cessation Intervention	Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
MT plus NRT with additional CM Group	Contingency Management Smoking Cessation Intervention	Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
CM plus NRT with additional MT Group	Nicotine Replacement Therapy	Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
CM plus NRT with additional MT Group	Mindfulness Training Smoking Cessation Intervention	Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
CM plus NRT with additional MT Group	Contingency Management Smoking Cessation Intervention	Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
MT plus NRT with additional CM Group	Nicotine Replacement Therapy	Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.

Primary Outcome Measures

Name	Time	Method
Number of participants reporting 7-day point-prevalence abstinence	Up to 22 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of enrolled participants	Baseline	Study feasibility will be reported as the number of participants that were screened and enrolled per month
Average enrollment time	Baseline	Study feasibility will be reported as the average time to enroll participants to form classes
Retention rate	Up to 22 weeks	Treatment specific retention rates will be reported as the number of participants completing all study procedures dived by the total of participants enrolled.
Number of completed study measures	Up to 22 weeks	Defined as number of in-person session attended, and number of homework assignments completed.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States