Tobacco Craving and Triggers in Persons With Schizophrenia
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/22/2016 |
| Start Date: | September 2013 |
| End Date: | May 2017 |
| Contact: | Ann Kearns, BS |
| Email: | akearns@mprc.umaryland.edu |
| Phone: | 410-402-6854 |
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schizophrenia(SWS)(Wehring et al, unpublished).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 to test
pre-identified environmental cues/triggers 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.
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 to test
pre-identified environmental cues/triggers 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.
Inclusion criteria
1. 18-55 year old males and females
2. currently smokes at least 10 cigarettes per day
3. current DSM-IV diagnosis of schizophrenia or schizoaffective disorder and stable
medication regimen
4. medically healthy as determined by screening criteria
5. urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
6. agrees to wear a head mounted display (HMD) for up to 45 minutes
7. participant able to complete the Evaluation to Sign Consent (ESC) with a minimum
score of 80% on ESC.
Exclusion criteria
1. interest in reducing or quitting tobacco use within the past 3 months
2. treatment for tobacco dependence in the past 3 months
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or
dependence within the past 6 months
5. current use of any medication that would interfere with the protocol in the opinion
of PI or investigators
6. history of head injury, seizures, or stroke
7. pregnant, nursing, or planning to become pregnant during the study
8. 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
We found this trial at
1
site
Click here to add this to my saved trials
