Status:
COMPLETED
Tobacco Craving and Triggers in Persons With Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Smoker
Schizophrenia Diagnosis
Eligibility:
All Genders
18-55 years
Brief Summary
Investigators have recently completed a pilot study exploring the safety and efficacy of using a virtual-reality based cue platform to elicit craving in smokers with schizophrenia(SWS)(Wehring et al, ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 18-55 year old males and females
- currently smokes at least 10 cigarettes per day
- current DSM-IV diagnosis of schizophrenia or schizoaffective disorder and stable medication regimen
- medically healthy as determined by screening criteria
- urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
- agrees to wear a head mounted display (HMD) for up to 45 minutes
- participant able to complete the Evaluation to Sign Consent (ESC) with a minimum score of 80% on ESC.
- Exclusion criteria
- interest in reducing or quitting tobacco use within the past 3 months
- treatment for tobacco dependence in the past 3 months
- use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or dependence within the past 6 months
- current use of any medication that would interfere with the protocol in the opinion of PI or investigators
- history of head injury, seizures, or stroke
- pregnant, nursing, or planning to become pregnant during the study
- positive urine toxicology screen for substances other than those used for therapeutic purposes: Participants who have an initial positive urine toxicology screen for substances other than those used for therapeutic purposes will will have the opportunity to return within two weeks for a second toxicology screen. If at that time the results are again positive, the participant will be excluded
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01846065
Start Date
September 1 2013
End Date
June 30 2017
Last Update
September 25 2019
Active Locations (1)
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1
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228