Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

NCT ID: NCT03873337

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2022-01-31

Brief Summary

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.

Detailed 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).

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NRT + Persistence Targeted Smoking Cessation in SMI

Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.

Group Type: EXPERIMENTAL

Persistence Targeted Smoking Cessation in SMI (PTSC-S)

Intervention Type: BEHAVIORAL

All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth

Nicotine patch

Intervention Type: DRUG

All participants will receive 10 weeks of nicotine patch

Interventions

Persistence Targeted Smoking Cessation in SMI (PTSC-S)

All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth

Intervention Type: BEHAVIORAL

Nicotine patch

All participants will receive 10 weeks of nicotine patch

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Marc L. Steinberg, Ph.D.

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc L Steinberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Locations

Division of Addiction Psychiatry

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R33DA041163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2018001696

Identifier Type: -

Identifier Source: org_study_id