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

Primary Purpose

Tobacco Use, Tobacco Smoking, Tobacco Use Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Persistence Targeted Smoking Cessation in SMI (PTSC-S)
Nicotine patch
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use focused on measuring tobacco, cigarette, schizophrenia, schizoaffective disorders, smoking cessation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Division of Addiction Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NRT + Persistence Targeted Smoking Cessation in SMI

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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".
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.
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.
Feasibility 3: Participant Attendance
Participants in the PTSC-S intervention will attend at least 60% of their sessions

Secondary Outcome Measures

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
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
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
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
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.
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.

Full Information

First Posted
March 11, 2019
Last Updated
August 19, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03873337
Brief Title
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Acronym
PTSC-S
Official Title
Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia, Schizoaffective Disorder
Keywords
tobacco, cigarette, schizophrenia, schizoaffective disorders, smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NRT + Persistence Targeted Smoking Cessation in SMI
Arm Type
Experimental
Arm Description
Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Persistence Targeted Smoking Cessation in SMI (PTSC-S)
Intervention Description
All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
All participants will receive 10 weeks of nicotine patch
Primary Outcome Measure Information:
Title
Acceptability 1: Participant Rating of Usefulness of Intervention
Description
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.
Time Frame
3-months post quit date (approximately 4-months after baseline assessment)
Title
Acceptability 2: Participant Rating of Counseling Session Length
Description
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.
Time Frame
3-months post quit date (approximately 4 months after baseline assessment)
Title
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
Description
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".
Time Frame
3-months post quit date (approximately 4 months after baseline assessment)
Title
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
Description
We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Time Frame
3-months post quit date (approximately 4 months after baseline assessment)
Title
Feasibility 2: Missing/Unusable Data
Description
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.
Time Frame
3-months post quit date (approximately 4 months after baseline assessment)
Title
Feasibility 3: Participant Attendance
Description
Participants in the PTSC-S intervention will attend at least 60% of their sessions
Time Frame
8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Secondary Outcome Measure Information:
Title
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
Description
No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm
Time Frame
End-of-counseling (8 weeks)
Title
Number of Participants With Prolonged Abstinence at End-of-counseling
Description
Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm
Time Frame
End-of-counseling (8 weeks)
Title
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
Description
No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO<8ppm
Time Frame
3-months post target quit date (approximately 4 months after baseline assessment)
Title
Number of Participants With Prolonged Abstinence at at 3-month Followup
Description
Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO<8ppm
Time Frame
3-months post target quit date (approximately 4 months after baseline assessment)
Title
Task Persistence Scores
Description
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.
Time Frame
2 months after baseline assessment and 4 months after baseline assessment
Title
Cigarettes Per Day
Description
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.
Time Frame
2 months after baseline assessment and 4 months after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc L Steinberg, Ph.D.
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Addiction Psychiatry
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

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