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

Not Applicable

Recruiting

• Conditions: Electronic Cigarette Use

• Registration Number: NCT05881304
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-05-31
• Study Start: 2024-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-07-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States