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

Last updated: May 6, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Standardized research e-cigarette (SREC)

Clinical Study ID

NCT05881304
2023p001364
K23DA056583
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 anMassachusetts General Hospital-affiliated primary care clinic (in treatment for >=3 months without changes in BUP dose in the past 2 weeks and planning toremain on current BUP treatment for >=3 months).

Exclusion

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 Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Standardized research e-cigarette (SREC)
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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