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Search / Trial NCT06609902

A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 19, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Bipolar Disorder Comorbid Tobacco Use Disorder Smoking Cessation

ClinConnect Summary

This clinical trial, called Future Self-BD, is designed to help adults with both bipolar disorder and tobacco use disorder. The goal is to support participants in quitting smoking by helping them imagine positive future experiences that could come from stopping smoking. This program includes six online sessions that take place on a secure platform called Zoom, led by Dr. Gold, the principal investigator.

To be eligible for this study, participants need to be at least 18 years old, have a diagnosis of bipolar disorder (either type I or II), and have a tobacco use disorder. They should be actively receiving treatment from a medical provider and taking a stable dose of mood-stabilizing medication. Additionally, they should smoke at least five cigarettes a day and be interested in quitting. It's important to note that participants should not be currently receiving any treatment specifically for quitting smoking. If you or someone you know fits these criteria and is interested in making a positive change, this study might be a great opportunity to consider!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults aged 18 or older
  • Have a diagnosis of BD I or II
  • Have a diagnosis of tobacco use disorder
  • Be engaged in outpatient treatment with a medical provider
  • Be on a stable dose of a mood-stabilizing medication
  • Smoke an average of at least 5 cigarettes per day for the past 30 days at baseline (based on the Heaviness of Smoking Index(Heatherton et al., 1989))
  • Be interested in quitting smoking
  • Not currently or in the past 3 months be receiving smoking cessation treatment.
  • Exclusion Criteria:
  • Current psychosis
  • Intent to harm oneself with an associated plan and intent to act on suicidal thoughts
  • Experiencing severe symptoms of depression and/or hypomania that may warrant a higher level of care (a Patient Health Questionnaire-9 total score ≥ 20(Kroenke et al., 2001) and/or an Altman Self-Rating Mania Scale total score ≥ 6(Altman et al., 1997) will trigger further clinician evaluation)

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

Alexandra K Gold, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported