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

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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.

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.

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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mi
from
New Brunswick, NJ
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