NCT05030272Completed
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 343 (actual)
- First submitted
- 26 Aug 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Schizophrenia, Depression, Bipolar disorder
- NCT number
- NCT05030272
What you commit to
- Study type: Interventional
- Participants enrolled: 343
- From 21 Sept 2021 to the primary completion date, 30 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
- Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
Other illness
- 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);
Other
- 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.
- Being pregnant or the intention to become pregnant in the next 6 months;
- 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).
Who the study is looking for
- DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
- Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
- Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
- Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
- Age 18 and older;
- Willing and medically eligible to use NRT;
- Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University at Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Wake Forest Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.