Testing Integrative Smoking Cessation for HIV Patients

University of Miami

Status and phase: Completed; Phase 4

Conditions: HIV Infections; Smoking; Smoking Cessation

Treatments: Behavioral: Contingency Management Smoking Cessation Intervention; Behavioral: Mindfulness Training Smoking Cessation Intervention; Drug: Nicotine Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05030766

20201296

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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95 participants in 4 patient groups

MT plus NRT Group-Phase 1

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Mindfulness Training Smoking Cessation Intervention

CM plus NRT Group-Phase1

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Contingency Management Smoking Cessation Intervention

MT plus NRT with additional CM Group-Phase2

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Mindfulness Training Smoking Cessation Intervention

Behavioral: Contingency Management Smoking Cessation Intervention

CM plus NRT with additional MT Group-Phase2

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Mindfulness Training Smoking Cessation Intervention

Behavioral: Contingency Management Smoking Cessation Intervention