Trial Outcomes & Findings for Predictors of Treatment Outcome for Smokers With and Without Schizophrenia (NCT NCT00501007)

Results Overview

Number of seconds participants continued working on a mirror tracing task before giving up.

Recruitment status

COMPLETED

Target enrollment

203 participants

Primary outcome timeframe

baseline

Results posted on

2017-07-17

Participant Flow

A total of 203 smokers were recruited from New Jersey state funded tobacco dependence treatment clinics, called QuitCenters, through clinician referrals or responses to recruitment flyers.

Reasons for exclusion included the following: Failed diagnostic screen, passed quit date/already using smoking cessation medications, changed mind about participating, smoked fewer than 10 cigarettes per day, did not have a goal to quit smoking, transportation issues, lost contact before baseline appointment, and low mini Mental Status Exam score.

Participant milestones

Participant milestones
Measure	Non-psychiatric Smokers Smokers without a diagnosis of schizophrenia or schizoaffective disorder	Smokers With Schizophrenia / Schizoaffective Disorder Smokers meeting criteria for schizophrenia or schizoaffective disorder
Overall Study STARTED	100	103
Overall Study COMPLETED	71	78
Overall Study NOT COMPLETED	29	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-psychiatric Smokers Smokers without a diagnosis of schizophrenia or schizoaffective disorder	Smokers With Schizophrenia / Schizoaffective Disorder Smokers meeting criteria for schizophrenia or schizoaffective disorder
Overall Study Inclusion criteria not met.	29	25

Baseline Characteristics

Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnosis n=203 Participants Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	203 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	44.12 years STANDARD_DEVIATION 10.97 • n=93 Participants
Sex: Female, Male Female	93 Participants n=93 Participants
Sex: Female, Male Male	110 Participants n=93 Participants
Region of Enrollment United States	203 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline

Population: All meeting inclusion criteria

Number of seconds participants continued working on a mirror tracing task before giving up.

Outcome measures

Outcome measures
Measure	Schizophrenia or Schizoaffective Disorder n=78 Participants Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder	Non-psychiatric Group n=71 Participants Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
Mirror-tracing Persistence (in Seconds)	61.08 seconds Standard Deviation 57.38	100.34 seconds Standard Deviation 73.23

SECONDARY outcome

Timeframe: 6 months

Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.

Outcome measures

Outcome measures
Measure	Schizophrenia or Schizoaffective Disorder n=149 Participants Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder	Non-psychiatric Group Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
Persistence as a Prospective Predictor of Smoking Cessation	1.014 Odds ratio Interval 1.014 to 1.017	—

Adverse Events

Diagnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc L. Steinberg, Ph.D.

Rutgers, The State University of New Jersey

Phone: 732-235-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place