Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01846065
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2013-04-02
Brief Title:
Tobacco Craving and Triggers in Persons With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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efficacy of using a virtual-reality based cue platform to elicit craving in smokers with schizophreniaSWSWehring et al unpublished In this study participants with schizophrenia n16 showed increased attention to cigarettes and changes in craving measures when participating in the VR craving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 triggerscues 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 schizophreniaSWS 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 to test pre-identified environmental cuestriggers and their effects on cue-elicited craving in 30 SWS Subjective reports mood and emotion measures and objective physiological measurements will be used to identify and quantify environmental craving responsivity as well as tonic craving
Given the high prevalence of smoking among individuals with schizophrenia understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes Establishing and validating a model of cue-elicited responsivity will allow future investigations of craving and ultimately designs for studying the efficacy of anti-craving medications in people with schizophrenia
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 triggerscues 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 schizophreniaSWS 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 to test pre-identified environmental cuestriggers and their effects on cue-elicited craving in 30 SWS Subjective reports mood and emotion measures and objective physiological measurements will be used to identify and quantify environmental craving responsivity as well as tonic craving
Given the high prevalence of smoking among individuals with schizophrenia understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes Establishing and validating a model of cue-elicited responsivity will allow future investigations of craving and ultimately designs for studying the efficacy of anti-craving medications in people with schizophrenia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None