Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Aug 26, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to help people with serious mental illnesses quit smoking. Researchers want to see if a new app called "Quit on the Go," which is designed specifically for people with mental health challenges, is more effective than the usual support methods for quitting smoking. The trial will take place at three locations: Duke University, the University at Buffalo, and Wake Forest University, and they are looking for participants who smoke at least five cigarettes a day and have a serious mental health condition like schizophrenia or bipolar disorder.
To join the study, participants need to be 18 years or older, have a diagnosis of a serious mental illness, and want to quit smoking within the next six months. It's also important that they are currently receiving treatment for their mental health. Participants can expect to use the app or receive standard smoking cessation support and will be monitored throughout the study to see how well each method works. This trial aims to find better ways to help individuals with mental health issues quit smoking, which is important for their overall health and wellbeing.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
- • 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
- • 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
- • 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
- • 5. Age 18 and older;
- • 6. Willing and medically eligible to use NRT;
- • 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
- • Exclusion Criteria
- • 1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
- • 2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
- • 3. Being pregnant or the intention to become pregnant in the next 6 months;
- • 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
- • 5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
- • 6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Winston Salem, North Carolina, United States
Durham, North Carolina, United States
Buffalo, New York, United States
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Roger Vilardaga, PhD
Principal Investigator
Wake Forest University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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