RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-06-03
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05881304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age
  2. * Report daily cigarette smoking (\>=10 cigarettes per day in the past week)
  3. * Not ready to quit smoking (not planning to quit in the next 30 days)
  4. * Willing to try e-cigarettes
  5. * 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).
  1. * Pregnant or breastfeeding
  2. * Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (\>3 days in past 30 days)
  3. * Report past 30-day use of behavioral or pharmacologic smoking cessation aids
  4. * Deemed inappropriate for participation by their OUD provider
  5. * Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy \<1 year).

Contacts and Locations

Study Contact

Joanna M Streck, PhD
CONTACT
617-643-9977
jstreck@mgh.harvard.edu

Principal Investigator

Joanna M Streck, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Joanna M Streck, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Electronic Cigarette Use