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Search / Trial NCT05881304

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 30, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring whether switching from regular cigarettes to a special research e-cigarette (called SREC) can help adults who are receiving treatment for opioid use disorder and are also daily smokers. The study aims to see if using the SREC is a good option for those who are not ready to quit smoking right now. Researchers will look at how many cigarettes people smoke each day, measure certain health markers, and check for any withdrawal symptoms or health effects from using the e-cigarette over a period of time.

To be eligible for this trial, participants must be at least 18 years old, smoke at least 10 cigarettes a day, and not be planning to quit smoking in the next month. They should also be stable on buprenorphine treatment for opioid use disorder for at least three months. During the study, 40 participants will be randomly assigned to either start using the SREC right away or wait eight weeks before receiving it. Throughout the study, participants will be monitored for a total of 12 to 20 weeks, depending on their group. This trial is currently recruiting participants at Massachusetts General Hospital-affiliated clinics.

Gender

ALL

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).

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Joanna M Streck, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported