Smoker Clinical Trial
NCT number | NCT01846065 |
Other study ID # | HP-00055208 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | June 30, 2017 |
Verified date | September 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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schizophrenia(SWS)(Wehring et al, unpublished).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.
Status | Completed |
Enrollment | 45 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Maryland Psychiatric Research Center | Catonsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between pre-identified environmental cues/triggers (social, environmental, or emotional cues) and their effects on the elicitation of craving in smokers with schizophrenia | 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 primarily emotional cues. | 1 Week |
Status | Clinical Trial | Phase | |
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