Testing Integrative Smoking Cessation for HIV Patients

NCT ID: NCT05030766

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2024-05-23

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.

Conditions

Smoking; Smoking Cessation; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MT plus NRT Group-Phase 1

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.

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type: DRUG

6 weeks of Nicotine replacement patches

Mindfulness Training Smoking Cessation Intervention

Intervention Type: BEHAVIORAL

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.

CM plus NRT Group-Phase1

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.

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type: DRUG

6 weeks of Nicotine replacement patches

Contingency Management Smoking Cessation Intervention

Intervention Type: BEHAVIORAL

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.

MT plus NRT with additional CM Group-Phase2

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.

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type: DRUG

6 weeks of Nicotine replacement patches

Mindfulness Training Smoking Cessation Intervention

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

CM plus NRT with additional MT Group-Phase2

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.

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type: DRUG

6 weeks of Nicotine replacement patches

Mindfulness Training Smoking Cessation Intervention

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

Nicotine Replacement Therapy

6 weeks of Nicotine replacement patches

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Taghrid Asfar

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taghrid A. Asfar, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20201296

Identifier Type: -

Identifier Source: org_study_id