N/A
N=34
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Tobacco Use · Tobacco Smoking · Tobacco Use Cessation · Tobacco Use Disorder · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT03873337 ↗Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Aug 2022
Primary outcome: Primary: Acceptability 1: Participant Rating of Usefulness of Intervention — 6.62; 6.58 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Persistence Targeted Smoking Cessation in SMI (PTSC-S) (Behavioral); Nicotine patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability 1: Participant Rating of Usefulness of Intervention |
6.62; 6.58 | — |
| PRIMARY Acceptability 2: Participant Rating of Counseling Session Length |
2.29 | — |
| PRIMARY Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date |
14; 2; 12 | — |
| PRIMARY Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date |
28 | — |
| PRIMARY Feasibility 2: Missing/Unusable Data |
184 | — |
| PRIMARY Feasibility 3: Participant Attendance |
1; 2; 5; 4; 22 | — |
| SECONDARY Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling |
3 | — |
| SECONDARY Number of Participants With Prolonged Abstinence at End-of-counseling |
2 | — |
| SECONDARY Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up |
3 | — |
| SECONDARY Number of Participants With Prolonged Abstinence at at 3-month Followup |
2 | — |
| SECONDARY Task Persistence Scores |
44.19; 47.39 | <0.001 sig |
| SECONDARY Cigarettes Per Day |
7.01; 8.48 | <0.001 sig |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03873337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.