Overview

Mind to Quit Multisite Trial

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
All

Summary

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 2 sites (Duke University and Univ. at Buffalo).

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Collaborators:

National Institutes of Health (NIH)
University at Buffalo

Treatments:

Nicotine

Criteria

Inclusion Criteria:

1. Current DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, or recurring major
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 ≥ 3 days in
the past 30 days.