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

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-Phase 1	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.
MT plus NRT Group-Phase 1	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.
CM plus NRT Group-Phase1	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-Phase1	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-Phase2	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.
MT plus NRT with additional CM Group-Phase2	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-Phase2	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-Phase2	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-Phase2	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-Phase2	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting 7-day Point-prevalence Abstinence	4 weeks (end of treatment), and 3 months	Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.

Secondary Outcome Measures

Name	Time	Method
Retention Rate	3 months	Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.
Treatment Specific Adherence Rates	3 months	Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).