Tobacco Dependence
Conditions
Brief summary
The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.
Detailed description
Please see brief summary above.
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers, The State University of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current smokers must be over the age of 18, * Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group. * Must smoke at least 10 cigarettes per day * Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.
Exclusion criteria
* Those unable to give informed consent. * Psychotic disorders other than schizophrenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mirror-tracing Persistence (in Seconds) | baseline | Number of seconds participants continued working on a mirror tracing task before giving up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence as a Prospective Predictor of Smoking Cessation | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Diagnosis Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder | 203 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inclusion criteria not met. | 29 | 25 |
Baseline characteristics
| Characteristic | Diagnosis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants |
| Age, Continuous | 44.12 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mirror-tracing Persistence (in Seconds)
Number of seconds participants continued working on a mirror tracing task before giving up.
Time frame: baseline
Population: All meeting inclusion criteria
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schizophrenia or Schizoaffective Disorder | Mirror-tracing Persistence (in Seconds) | 61.08 seconds | Standard Deviation 57.38 |
| Non-psychiatric Group | Mirror-tracing Persistence (in Seconds) | 100.34 seconds | Standard Deviation 73.23 |
Secondary
Persistence as a Prospective Predictor of Smoking Cessation
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Schizophrenia or Schizoaffective Disorder | Persistence as a Prospective Predictor of Smoking Cessation | 1.014 Odds ratio |