- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881304
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC (SWITCHED)
March 11, 2024 updated by: Joanna M. Streck, Ph.D., Massachusetts General Hospital
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joanna M Streck, PhD
- Phone Number: 617-643-9977
- Email: jstreck@mgh.harvard.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate SREC provision (iSREC)
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.
|
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.
Other Names:
|
Active Comparator: Delayed SREC provision waitlist control (WLC)
Those in the WLC condition will receive SREC provision after an 8-week delay.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cigarettes smoked per day
Time Frame: Baseline 2 to 8 weeks
|
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).
|
Baseline 2 to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study enrollment
Time Frame: Baseline
|
Proportion of those screened identified as eligible.
Proportion of those identified as eligible at screening who enroll in trial.
|
Baseline
|
E-cigarette use during e-cigarette provision
Time Frame: During the 8 weeks of 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
|
During the 8 weeks of e-cigarette provision
|
Breath carbon monoxide
Time Frame: Baseline 1-Week 8
|
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.
|
Baseline 1-Week 8
|
Anabasine
Time Frame: Baseline 1-Week 8
|
Change in anabasine - during e-cigarette provision.
Change in urine anabasine level (ng/ml)from Baseline 1 to Week 8 between randomized groups.
|
Baseline 1-Week 8
|
Study completion
Time Frame: Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)
|
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.
|
Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanna M Streck, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 19, 2023
First Submitted That Met QC Criteria
May 30, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023p001364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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