Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

NCT03873337 | Completed Results DMC

• 2 other identifiers: Pro2018001696R33DA041163
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

tobacco; cigarette; schizophrenia; schizoaffective disorders; smoking cessation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling

  End-of-counseling (8 weeks)

• Number of Participants With Prolonged Abstinence at End-of-counseling

  End-of-counseling (8 weeks)

• Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up

  3-months post target quit date (approximately 4 months after baseline assessment)

• Number of Participants With Prolonged Abstinence at at 3-month Followup

  3-months post target quit date (approximately 4 months after baseline assessment)

• Task Persistence Scores

  2 months after baseline assessment and 4 months after baseline assessment

Study Arms (1)

NRT + Persistence Targeted Smoking Cessation in SMI

EXPERIMENTAL

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); Drug: Nicotine patch

Interventions

Persistence Targeted Smoking Cessation in SMI (PTSC-S) BEHAVIORAL

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

NRT + Persistence Targeted Smoking Cessation in SMI

Nicotine patch DRUG

All participants will receive 10 weeks of nicotine patch

NRT + Persistence Targeted Smoking Cessation in SMI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia; Psychotic Disorders; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Smoking; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Marc L. Steinberg, Ph.D.
• Organization: Rutgers Robert Wood Johnson Medical School

marc.steinberg@rutgers.edu

732-235-4341

Study Officials

• Marc L Steinberg, Ph.D.

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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 Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: April 22, 2019
• Primary Completion: January 10, 2022
• Study Completion: January 31, 2022
• Last Updated: September 13, 2022
• Results First Posted: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available once the study has been completed and primary and secondary outcomes have been published.
• 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.

Locations

US (1)