SmokerNCT01846065
Tobacco Craving and Triggers in Persons With Schizophrenia
An observational study of Smoker and Schizophrenia Diagnosis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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of using a virtual-reality based cue platform to elicit craving in smokers with schizophrenia(SWS)(Wehring et al, unpublished). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Smoker, Schizophrenia Diagnosis
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will include: current smokers with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder. Participants with schizophrenia will be considered on a stable medication regimen if they have received their current antipsychotic medication(s) for at least 6 weeks and the same dose for at least 30 days.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
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.
- Conditions
- Smoker, Schizophrenia Diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Heidi Wehring, Pharm.D., BCPP, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846065
- Sponsor's protocol ID
- HP-00055208
- Status last verified
- Sep 2019
- First submitted
- 2 Apr 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Craving and Triggers in Persons With Schizophrenia
- ClinicalTrials.gov ID
- NCT01846065
- Acronym / sponsor ID
- HP-00055208
- Conditions
- Smoker, Schizophrenia Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include: current smokers with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder. Participants with schizophrenia will be considered on a stable medication regimen if they have received their current antipsychotic medication(s) for at least 6 weeks and the same dose for at least 30 days.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between pre-identified environmental cues/triggers (social, environmental, or emotional cues) and their effects on the elicitation of craving in smokers with schizophrenia
Time frame: 1 Week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Maryland Psychiatric Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Wehring, Pharm.D., BCPP principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoker and Schizophrenia Diagnosis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between pre-identified environmental cues/triggers (social, environmental, or emotional cues) and their effects on the elicitation of craving in smokers with schizophrenia (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.