Mind to Quit Trial (Smoking Cessation) - Clinical Trial

What is the Purpose of this Study?


We are doing this study to compare 2 different approaches to help people quit smoking. We want to know which of these approaches is most likely to help smokers who have a mental illness and want to stop smoking.

What is the Condition Being Studied?

Smoking Cessation for People with Mental Illness

Who Can Participate in the Study?

Key Eligibility

Adults ages 18+ who:
- Are diagnosed with one of the following: depression, schizophrenia, schizoaffective disorder, or bipolar disorder
- Are receiving treatment for mental health (therapy and/or medication) and plan to continue this treatment while enrolled in the study
- Smoke every day
- Want to quit smoking
- Own an Apple or Android smartphone with a data plan
- Do not regularly use e-cigarettes or any other tobacco product besides regular cigarettes
- Are willing to use nicotine replacement therapy products (patches and gum)

For more information about who can join this study, please contact the study team at anthony.devito@duke.edu.

Age Group

What is Involved?


If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- One group will use nicotine gum and patches and receive direct advice from a team member about strategies to use to help quit smoking
-- The other group will use nicotine gum and patches and download a mobile app that is being developed to help people quit smoking
- Have 5 Zoom calls with the study team
- Answer questionnaires
- Receive a supply of nicotine patches and gum
- Do breath test(s) for carbon monoxide levels (if you report that you've quit smoking)

Participation in the study will last for about 6 months. We will compensate your for your time on the study.

You can visit our website to get in touch with us and let us know you are interested: http://trianglesmokingstudies.com/i-want-to-quit-smoking/

Study Details

Full Title
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Principal Investigator
Roger Vilardaga
Protocol Number
IRB: PRO00103637
NCT: NCT05030272
Phase III
Enrollment Status
Open for Enrollment