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

NCT ID: NCT05881304

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Standardized research e-cigarette (SREC)

Intervention Type: 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.

Delayed SREC provision waitlist control (WLC)

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

Group Type: ACTIVE_COMPARATOR

Standardized research e-cigarette (SREC)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SREC

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 <1 year).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joanna M. Streck, Ph.D.

Assistant Professor in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna M Streck, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joanna M Streck, PhD

Role: CONTACT

jstreck@mgh.harvard.edu

617-643-9977

Facility Contacts

Joanna M Streck, PhD

Role: primary

jstreck@mgh.harvard.edu

617-643-9977

Michele Reyen, MPH

Role: backup

mreyen@mgh.harvard.edu

Other Identifiers

K23DA056583

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023p001364

Identifier Type: -

Identifier Source: org_study_id