Clinical trial

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

Name

20201296

Description

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.

Trial arms

Trial start

2022-01-04

Estimated PCD

2024-12-09

Trial end

2024-12-09

Status

Recruiting

Phase

Early phase I

Treatment

Nicotine Replacement Therapy

6 weeks of Nicotine replacement patches

Arms:

CM plus NRT Group, CM plus NRT with additional MT Group, MT plus NRT Group, MT plus NRT with additional CM Group

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.

Arms:

CM plus NRT with additional MT Group, MT plus NRT Group, MT plus NRT with additional CM Group

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.

Arms:

CM plus NRT Group, CM plus NRT with additional MT Group, MT plus NRT with additional CM Group

Size

100

Primary endpoint

Number of participants reporting 7-day point-prevalence abstinence

Up to 22 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-05-21

1 organization

1 product

3 indications

Organization

University of Miami

Product

Nicotine Replacement Therapy

Indication

Tobacco use disorder

Indication

tobacco dependence

Indication

HIV Infections