Clinical trial NCT03873337: Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Official title: Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Tobacco Smoking
Tobacco Use Cessation
Tobacco Use Disorder
Schizophrenia
Schizoaffective Disorder
Keywords: tobacco
cigarette
schizophrenia
schizoaffective disorders
smoking cessation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-03-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Acceptability 1: Participant Rating of Usefulness of Intervention
timeFrame: 3-months post quit date (approximately 4-months after baseline assessment)
measure: Acceptability 2: Participant Rating of Counseling Session Length
timeFrame: 3-months post quit date (approximately 4 months after baseline assessment)
measure: Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
timeFrame: 3-months post quit date (approximately 4 months after baseline assessment)
measure: Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
timeFrame: 3-months post quit date (approximately 4 months after baseline assessment)
measure: Feasibility 2: Missing/Unusable Data
timeFrame: 3-months post quit date (approximately 4 months after baseline assessment)
measure: Feasibility 3: Participant Attendance
timeFrame: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Secondary outcomes:
measure: Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
timeFrame: End-of-counseling (8 weeks)
measure: Number of Participants With Prolonged Abstinence at End-of-counseling
timeFrame: End-of-counseling (8 weeks)
measure: Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
timeFrame: 3-months post target quit date (approximately 4 months after baseline assessment)
measure: Number of Participants With Prolonged Abstinence at at 3-month Followup
timeFrame: 3-months post target quit date (approximately 4 months after baseline assessment)
measure: Task Persistence Scores
timeFrame: 2 months after baseline assessment and 4 months after baseline assessment
measure: Cigarettes Per Day
timeFrame: 2 months after baseline assessment and 4 months after baseline assessment
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Division of Addiction Psychiatry
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Marc L Steinberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: