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

Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Tobacco Use; Tobacco Smoking; Tobacco Use Disorder; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S); Drug: Nicotine patch

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).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Division of Addiction Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S); All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth; Drug: Nicotine patch; All participants will receive 10 weeks of nicotine patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability 1: Participant Rating of Usefulness of Intervention	After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.	3-months post quit date (approximately 4-months after baseline assessment)
Acceptability 2: Participant Rating of Counseling Session Length	After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.	3-months post quit date (approximately 4 months after baseline assessment)
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date	We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".	3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date	We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.	3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 2: Missing/Unusable Data	We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.	3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 3: Participant Attendance	Participants in the PTSC-S intervention will attend at least 60% of their sessions	8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling	No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm	End-of-counseling (8 weeks)
Number of Participants With Prolonged Abstinence at End-of-counseling	Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm	End-of-counseling (8 weeks)
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up	No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO<8ppm	3-months post target quit date (approximately 4 months after baseline assessment)
Number of Participants With Prolonged Abstinence at at 3-month Followup	Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO<8ppm	3-months post target quit date (approximately 4 months after baseline assessment)
Task Persistence Scores	14-item Thoughts About Smoking Questionnaire (TASQ). Lower scores represent greater task persistence. The total score can range from a minimum of 14 to a maximum of 98.	2 months after baseline assessment and 4 months after baseline assessment
Cigarettes Per Day	Hypothesis 3: As compared to baseline, participants will report smoking fewer cigarettes per day at 2- and 4-months post-baseline. Analysis 3: One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day on the TASQ at each timepoint.	2 months after baseline assessment and 4 months after baseline assessment

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Marc L Steinberg, Ph.D., Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: schizophrenia; smoking cessation; tobacco; cigarette; schizoaffective disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro2018001696; R33DA041163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Requests for de-identified data from qualified researchers will be considered once the study has been completed.
• IPD Sharing Time Frame: Data will become available once the study has been completed and primary and secondary outcomes have been published.
• IPD Sharing Access Criteria: Requests will be evaluated by the principal investigator. Access will be granted to the scientific researchers providing a valid scientific rationale for the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No