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Completed NCT05881304

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

Conditions: Electronic Cigarette Use

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 41
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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).

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05881304). StuddyBuddy aggregates publicly available trial information.