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NCT01846065 · ClinicalTrials.gov registry record
Tobacco Craving and Triggers in Persons With Schizophrenia
A clinical trial of Smoker and Schizophrenia Diagnosis, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT01846065: Completed study of Smoker and Schizophrenia Diagnosis, sponsored by University of Maryland, Baltimore.
NCT01846065 is a study of Smoker and Schizophrenia Diagnosis that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 45 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846065, a study of Smoker and Schizophrenia Diagnosis, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
Study 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of using a virtual-reality based cue platform to elicit craving in smokers with schizophrenia(SWS)(Wehring et al, unpublished). In this study, participants with schizophrenia (n=16) showed increased attention to cigarettes and changes in craving measures when participating in the VR craving platform. In addition, participants tolerated the VR environment without undue adverse effects or exacerbation of symptoms. Adverse effects from the VR environment did not differ from that in a non-mentally ill population, and included headache, nausea, and dizziness as most commonly occurring factors. Persons in this pilot also showed acceptable rates of Immersion and Presence in the VR environment, showing the potential use of this form of environment for this and other purposes. In this study, investigators will examine virtual reality cue-reactivity in smokers with schizophrenia, with a focus on the relationship of cue-reactivity with self-identified triggers/cues. Smokers with schizophrenia often identify specific cues that trigger craving. Many of these are environmental (scent, sight of smoking paraphernalia or cigarettes, related objects, or social situations), however, a significant amount of smokers describe emotionally-based factors (sadness, being upset, etc.) as primary cues and triggers. Most methods used to elicit craving in experimental studies are executed via using environmental cues like sight of cigarettes or smoking paraphernalia. It is not known if smokers with schizophrenia(SWS) who are strongly emotionally triggered will be responsive to environmental triggers in a cue-elicited craving platform. This is an important research question, as the testing of anti-craving interventions should be generalizable for use across SWS with differing triggers to smoking. The VR-based environmental program from our pilot study, which includes sight, scent, and social cues, will be used
Primary Outcome
Hypothesis: Based on our pilot data, we hypothesize that smokers with schizophrenia who identify specific environmental cues/triggers of smoking will experience greater self-reported craving as reported by craving on a visual analogue scale and a Tobacco Craving Questionnaire scale as well as physiological responsivity (blood pressure, heart rate, skin conductance) when exposed to environmental smoking cues compared to neutral cues, and will differ from the responsivity of smokers who identify p
Conditions Studied
Study Locations (1)
Maryland
- Maryland Psychiatric Research Center - Catonsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-06-30 |
What the finished NCT01846065 record still lists
NCT01846065 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 2 conditions, with Smoker appearing as the primary indexed condition, and to 0 interventions.
NCT01846065 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01846065 about?
NCT01846065 is a clinical study titled "Tobacco Craving and Triggers in Persons With Schizophrenia". 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, unpublished). In this study, participants with schizophrenia (n=16) showed increased attention to ci...
What is the current status of trial NCT01846065?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2013-09. Estimated completion is 2017-06-30.
What conditions does trial NCT01846065 study?
This clinical trial studies the following conditions: Smoker, Schizophrenia Diagnosis.
Who is sponsoring clinical trial NCT01846065?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01846065 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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