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

NCT05881304 | Completed

• 2 other identifiers: 2023p001364K23DA056583
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (1)

• Cigarettes smoked per day

  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 Outcomes (5)

• Study enrollment

  Baseline

• E-cigarette use during e-cigarette provision

  During the 8 weeks of e-cigarette provision

• Breath carbon monoxide

  Baseline 1-Week 8

• Anabasine

  Baseline 1-Week 8

• Study completion

  Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)

Study Arms (2)

Immediate SREC provision (iSREC)

EXPERIMENTAL

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)

Delayed SREC provision waitlist control (WLC)

ACTIVE COMPARATOR

Those in the WLC condition will receive SREC provision after an 8-week delay.

Device: Standardized research e-cigarette (SREC)

Interventions

Standardized research e-cigarette (SREC) DEVICE

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.

Also known as: SREC

Delayed SREC provision waitlist control (WLC); Immediate SREC provision (iSREC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Joanna M Streck, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Psychiatry

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 3, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)