Persistence Targeted Smoking Cessation in Schizophrenia
Status: | Recruiting |
---|---|
Conditions: | Schizophrenia, Smoking Cessation, Smoking Cessation, Smoking Cessation, Smoking Cessation, Psychiatric, Tobacco Consumers |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/16/2019 |
Start Date: | March 11, 2019 |
End Date: | December 31, 2021 |
Contact: | Jessica Research Coordinator |
Email: | jco74@rwjms.rutgers.edu |
Phone: | 732-235-4600 |
A Randomized Clinical Trial of Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
The investigators will conduct a randomized clinical trial to test the feasibility, initial
efficacy, and mechanisms of action of our PTSC-S intervention.
efficacy, and mechanisms of action of our PTSC-S intervention.
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.
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.
Inclusion Criteria:
- Must be between 18 - 70 years old
- Must indicate willingness to make a quit attempt in the next 30 days
- Must smoke at least 5 cigarettes (including those labeled "little cigars") per day for
past month
- Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use
- Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured
Clinical Interview (SCID-5)
- Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8
weeks, and a stable psychotropic medication regimen including a stable antipsychotic
dose for 8 weeks
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
We found this trial at
1
site
New Brunswick, New Jersey 08901
Principal Investigator: Marc L Steinberg, Ph.D.
Phone: 732-235-4341
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