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Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC (SWITCHED)

Primary Purpose

Electronic Cigarette Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized research e-cigarette (SREC)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electronic Cigarette Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years of age Report daily cigarette smoking (>=10 cigarettes per day in the past week) Not ready to quit smoking (not planning to quit in the next 30 days) Willing to try e-cigarettes In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for >=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for >=3 months). Exclusion Criteria: Pregnant or breastfeeding Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (>3 days in past 30 days) Report past 30-day use of behavioral or pharmacologic smoking cessation aids Deemed inappropriate for participation by their OUD provider Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy <1 year).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Immediate SREC provision (iSREC)

    Delayed SREC provision waitlist control (WLC)

    Arm Description

    Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC.

    Those in the WLC condition will receive SREC provision after an 8-week delay.

    Outcomes

    Primary Outcome Measures

    Cigarettes smoked per day
    Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from Baseline 2 to Week 8 comparing between randomized groups (iSREC group vs. WLC).

    Secondary Outcome Measures

    Study enrollment
    Proportion of those screened identified as eligible. Proportion of those identified as eligible at screening who enroll in trial.
    E-cigarette use during e-cigarette provision
    Mean days of e-cigarette use in past 7 days. 1) Number of days of e-cigarette use in past 7 days at Weeks 2, 4, 6, and 8 between randomized groups, and 2) number of days of e-cigarette use in the past 7 days in a pre-post analysis that combines randomized groups
    Breath carbon monoxide
    Change in expired air carbon monoxide (CO)- during e-cigarette provision. Change in expired air CO (ppm) from Baseline to Week 8 between randomized groups.
    Anabasine
    Change in anabasine - during e-cigarette provision. Change in urine anabasine level (ng/ml)from Baseline 1 to Week 8 between randomized groups.
    Study completion
    Proportion of patients who complete the trial, defined as completing the final follow-up assessment (12 weeks for iSREC and 20 weeks for WLC) and >=50% of the study visits.

    Full Information

    First Posted
    May 19, 2023
    Last Updated
    May 30, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05881304
    Brief Title
    Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
    Acronym
    SWITCHED
    Official Title
    Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day [primary outcome], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control [WLC]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Electronic Cigarette Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate SREC provision (iSREC)
    Arm Type
    Experimental
    Arm Description
    Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC.
    Arm Title
    Delayed SREC provision waitlist control (WLC)
    Arm Type
    Active Comparator
    Arm Description
    Those in the WLC condition will receive SREC provision after an 8-week delay.
    Intervention Type
    Device
    Intervention Name(s)
    Standardized research e-cigarette (SREC)
    Other Intervention Name(s)
    SREC
    Intervention Description
    Patients will be provided with NIDA's standardized research electronic cigarette (SREC) for 8-weeks and asked to attempt to substitute the SREC for combusted cigarettes during the 8 weeks. Participants will be randomized in a 1:1 ratio to 1 of 2 conditions for 8 weeks: 1) immediate standardized research e-cigarette provision (iSREC) or 2) delayed SREC provision waitlist control (WLC). Those randomized to the iSREC group will be provided a free 8-week supply of SRECs and asked to try to switch completely to the SREC. Those in the WLC condition will receive SREC provision after an 8-week delay.
    Primary Outcome Measure Information:
    Title
    Cigarettes smoked per day
    Description
    Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from Baseline 2 to Week 8 comparing between randomized groups (iSREC group vs. WLC).
    Time Frame
    Baseline 2 to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Study enrollment
    Description
    Proportion of those screened identified as eligible. Proportion of those identified as eligible at screening who enroll in trial.
    Time Frame
    Baseline
    Title
    E-cigarette use during e-cigarette provision
    Description
    Mean days of e-cigarette use in past 7 days. 1) Number of days of e-cigarette use in past 7 days at Weeks 2, 4, 6, and 8 between randomized groups, and 2) number of days of e-cigarette use in the past 7 days in a pre-post analysis that combines randomized groups
    Time Frame
    During the 8 weeks of e-cigarette provision
    Title
    Breath carbon monoxide
    Description
    Change in expired air carbon monoxide (CO)- during e-cigarette provision. Change in expired air CO (ppm) from Baseline to Week 8 between randomized groups.
    Time Frame
    Baseline 1-Week 8
    Title
    Anabasine
    Description
    Change in anabasine - during e-cigarette provision. Change in urine anabasine level (ng/ml)from Baseline 1 to Week 8 between randomized groups.
    Time Frame
    Baseline 1-Week 8
    Title
    Study completion
    Description
    Proportion of patients who complete the trial, defined as completing the final follow-up assessment (12 weeks for iSREC and 20 weeks for WLC) and >=50% of the study visits.
    Time Frame
    Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years of age Report daily cigarette smoking (>=10 cigarettes per day in the past week) Not ready to quit smoking (not planning to quit in the next 30 days) Willing to try e-cigarettes In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for >=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for >=3 months). Exclusion Criteria: Pregnant or breastfeeding Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (>3 days in past 30 days) Report past 30-day use of behavioral or pharmacologic smoking cessation aids Deemed inappropriate for participation by their OUD provider Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy <1 year).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joanna M Streck, PhD
    Phone
    617-643-9977
    Email
    jstreck@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joanna M Streck, PhD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC

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