SWITCHED: Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Device: Standardized research e-cigarette (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:
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| Active Comparator: Delayed SREC provision waitlist control (WLC) Those in the WLC condition will receive SREC provision after an 8-week delay. |
Device: Standardized research e-cigarette (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:
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Outcome Measures
Primary Outcome Measures
- Cigarettes smoked per day [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).
Secondary Outcome Measures
- Study enrollment [Baseline]
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 [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
- Breath carbon monoxide [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.
- Anabasine [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.
- Study completion [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age
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Report daily cigarette smoking (>=10 cigarettes per day in the past week)
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Not ready to quit smoking (not planning to quit in the next 30 days)
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Willing to try e-cigarettes
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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:
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Pregnant or breastfeeding
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Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (>3 days in past 30 days)
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Report past 30-day use of behavioral or pharmacologic smoking cessation aids
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Deemed inappropriate for participation by their OUD provider
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Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy <1 year).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Joanna M Streck, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023p001364