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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Joanna M Streck, PhD
jstreck@mgh.harvard.edu
617-643-9977
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Active_comparator: Delayed SREC provision waitlist control (WLC)
Those in the WLC condition will receive SREC provision after an 8-week delay.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov