Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) (PTSC-S)

Rutgers The State University of New Jersey

Status

Completed

Conditions

Tobacco Use Disorder

Tobacco Use Cessation

Schizophrenia

Schizoaffective Disorder

Tobacco Smoking

Tobacco Use

Treatments

Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S)

Drug: Nicotine patch

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03873337

Pro2018001696

R33DA041163 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.

Full description

The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.

We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified <8ppm).

Enrollment

34 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be between 18 - 70 years old
Must indicate willingness to make a quit attempt in the next 30 days
Must report being a daily cigarette smoker (including those labeled "little cigars") for past month
Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV)
Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks
Must have a smartphone, tablet, or computer with ability to download apps
Must currently receive mental health treatment
Must sign release of information for current mental health treatment providers

Exclusion criteria

Must not currently (in past 10 days) be taking varenicline (Chantix),
Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
Must not have pending legal matters with potential to result in jail time
Must not be planning on moving outside local area in next 3-months
Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)