Persistence Targeted Smoking Cessation in Schizophrenia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Schizoaffective Disorder
- Schizophrenia
- Tobacco Smoking
- Tobacco Use
- Tobacco Use Cessation
- Tobacco Use Disorder
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: We will randomized participants to one of two counseling interventions, "Persistence Targeted Smoking Cessation for Schizophrenia (PTSC-S)" or a modified version of "Clearing the Air (CTA)"Masking: Single (Outcomes Assessor)Masking Description: Outcomes assessors will not be informed to which intervention the participants are randomized.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
The investigators will conduct a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention as compared to a time-matched intervention that does not address task persistence. The investigators hypothesize that participants will attend at ...
The investigators will conduct a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention as compared to a time-matched intervention that does not address task persistence. The investigators hypothesize that participants will attend at least 60% of PTSC-S treatment sessions and that those attending the PTSC-S treatment sessions will have a larger percentage of abstinent days and larger rates of prolonged- and 7-day point prevalence abstinence (all biochemically verified with CO<8ppm) at end-of-treatment and 3-months post quit-date as compared to those attending an active, time-matched control intervention based on the NCI's Clearing the Air intervention. The investigators hypothesize that PTSC-S will result in greater task persistence than will a control treatment and that greater changes in task persistence will be related to greater abstinence rates. While a Stage 1b therapy development study such as this is likely to be underpowered to detect mediation, the investigators will nevertheless test an exploratory mediational hypothesis that PTSC-S has its effect on smoking abstinence primarily through its effect on task persistence.
Tracking Information
- NCT #
- NCT03873337
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Principal Investigator: Marc L Steinberg, Ph.D. Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University