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Testing Integrative Smoking Cessation for HIV Patients

Primary Purpose

Smoking, Smoking Cessation, HIV Infections

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine Replacement Therapy
Mindfulness Training Smoking Cessation Intervention
Contingency Management Smoking Cessation Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Smoking focused on measuring Mindfulness Training, Contingency Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

MT plus NRT Group

CM plus NRT Group

MT plus NRT with additional CM Group

CM plus NRT with additional MT Group

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of participants reporting 7-day point-prevalence abstinence
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

Number of enrolled participants
Study feasibility will be reported as the number of participants that were screened and enrolled per month
Average enrollment time
Study feasibility will be reported as the average time to enroll participants to form classes
Retention rate
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
Defined as number of in-person session attended, and number of homework assignments completed.

Full Information

First Posted
August 26, 2021
Last Updated
October 13, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05030766
Brief Title
Testing Integrative Smoking Cessation for HIV Patients
Official Title
A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation, HIV Infections
Keywords
Mindfulness Training, Contingency Management

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT plus NRT Group
Arm Type
Experimental
Arm 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.
Arm Title
CM plus NRT Group
Arm Type
Experimental
Arm 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.
Arm Title
MT plus NRT with additional CM Group
Arm Type
Experimental
Arm 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.
Arm Title
CM plus NRT with additional MT Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy
Intervention Description
6 weeks of Nicotine replacement patches
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training Smoking Cessation Intervention
Intervention Description
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
Intervention Name(s)
Contingency Management Smoking Cessation Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants reporting 7-day point-prevalence abstinence
Description
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.
Time Frame
Up to 22 weeks
Secondary Outcome Measure Information:
Title
Number of enrolled participants
Description
Study feasibility will be reported as the number of participants that were screened and enrolled per month
Time Frame
Baseline
Title
Average enrollment time
Description
Study feasibility will be reported as the average time to enroll participants to form classes
Time Frame
Baseline
Title
Retention rate
Description
Treatment specific retention rates will be reported as the number of participants completing all study procedures dived by the total of participants enrolled.
Time Frame
Up to 22 weeks
Title
Number of completed study measures
Description
Defined as number of in-person session attended, and number of homework assignments completed.
Time Frame
Up to 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taghrid Asfar, MD, MSPH
Phone
3052433826
Email
tasfar@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura McClure, MSPH
Phone
5185848391
Email
lmcclure@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taghrid A. Asfar, MD, MSPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taghrid Asfar, MD, MSPH
Phone
305-243-3826
Email
tasfar@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Taghrid Asfar, MD, MSPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Testing Integrative Smoking Cessation for HIV Patients

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