Status:
COMPLETED
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Tobacco Smoking
Eligibility:
All Genders
18-70 years
Phase:
NA
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 accept...
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 incre...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03873337
Start Date
April 22 2019
End Date
January 31 2022
Last Update
September 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Addiction Psychiatry
New Brunswick, New Jersey, United States, 08901