Cannabis UseNCT01212081
Assessment of Cannabis Craving in Schizophrenia Using Virtual Reality
An observational study of Cannabis Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Individuals with schizophrenia or schizoaffective disorders have a high prevalence of cannabis use. Understanding some of the environmental factors that maintain cannabis use, such as socially triggered cravings, is a critical step in improving treatment for cannabis dependence. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2010to 26 Nov 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 year old males and females
- Lifetime history of at least 50 cannabis uses and average cannabis use of once per month (or average use of once per month prior to hospitalization, if inpatient)
- Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Stable antipsychotic regimen (4 weeks on antipsychotic regimen and 30 days at current dose)
- Medically healthy as determined by screening criteria
- Agrees to wear a head mounted display (HMD) for a period of time generally not exceeding 45 minutes
Who cannot join
- DSM-IV diagnosis of active alcohol or substance abuse (besides cannabis or nicotine) 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 MAI (dronabinol, varenicline, bupropion, etc)
- History of head injury, seizures, stroke, or severe motion sickness
- Positive urine toxicology screen for agents besides cannabis for substances other than cannabis or those used for therapeutic purposes: Participants who have an initial positive urine toxicology screen for substances other than those used for therapeutic purposes or cannabis 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.
- Positive pregnancy test (if female)
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Background:
- Individuals with schizophrenia or schizoaffective disorders have a high prevalence of cannabis use. Understanding some of the environmental factors that maintain cannabis use, such as socially triggered cravings, is a critical step in improving treatment for cannabis dependence. In recent years, virtual reality has been studied to determine whether it can be used to induce craving by using life-like cue settings. Researchers are interested in using virtual reality systems to study cannabis cravings in individuals with schizophrenia.
Read more
Objectives:
- To determine if virtual reality cues will elicit cannabis craving in persons with schizophrenia who have a history of cannabis use.
Eligibility:
- Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia or schizoaffective disorders, are on a stable antipsychotic medication, and who have a lifetime history of at least 50 cannabis uses and average cannabis use of once per month.
Design:
- This study involves an initial screening visit, a study visit, and a followup visit.
- Participants will be screened with a medical history and physical examination, and will complete questionnaires about their history of marijuana and other drug use. Participants will also learn how to use the virtual reality equipment at this visit.
- During the study visit, participants will respond to marijuana cues using the virtual reality system while researchers monitor their heart rate, blood pressure, and sweat levels.
- At the followup visit, participants will complete questionnaires about their mood and any cravings for marijuana.
Read the detailed description
Objective: The use of cannabis is prevalent in people with schizophrenia, and has been linked both to onset of illness and worsening of symptoms. Craving in persons with schizophrenia who use cannabis has not been widely studied. The occurrence of craving may lead to relapse in substance use disorders. Therefore, craving paradigms in people with schizophrenia need to be optimized in order to test new treatments on craving measures in this population. Thus, the purpose of this study is to determine the feasibility and effects of virtual reality cues on craving intensity for cannabis in patients with schizophrenia
Study population: We will enroll 25 persons with a DSM IV diagnosis of schizophrenia who have a lifetime history of at least 50 lifetime uses of cannabis and cannabis use an average of at least once per month (or, if inpatients, average use of once per month prior to hospitalization) with a goal of 16 completers.
Design: This study uses a comparison-controlled, within-subject design. All subjects will undergo a baseline assessment and acclimation period and then participate in an experimental condition in which four cues will be presented in separate rooms in the VR program. These include two cannabis cues and two neutral cues in four different rooms. A follow up session for craving and symptom assessments will occur one week after the experimental session.
Outcome Measures:
At the end of each of the four cues, the Cannabis Craving Scale (CCVAS), Cannabis Attention scale (CAS), the Marijuana Craving Questionnaire-Short Form (MCQ-SF), and a visual analog cigarette craving item will be administered to measure craving during the virtual reality session. The CCVAS and CAS will be projected into the VR environment and participants will respond via hand controller. The MCQ-SF will also be administered, as well as the Mood form , to assess mood, at baseline as well as at the end of each of the 4 cues. Before and after the experimental session participants will also be rated on the Brief Psychiatric Rating Scale (BPRS), Schedule for the Assessment of Negative Symptoms (SANS), side effects, and the State-Trait Anxiety Inventory (STAI). The Immersion Questionnaire and Imagery Realism Presence Questionnaire (PQ) will be given at the conclusion of the experimental session. Before and after the session, as well as during the experiment participants will be monitored for physiological reactivity (heart rate, blood pressure, and skin conductance response) to cues of cannabis use as well as neutral cues measured.
- Conditions
- Cannabis Use
- Keywords
- Virtual Reality, Schizophrenia, Cannabis, Assessment, Craving
- Medical subject headings
- Schizophrenia, Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary measures include the Cannabis Craving Scale, Cannabis Attention Scale, and Marijuana Craving Questionnaire-Short Form, assessed after each cue. Physiological measures (blood pressure, heart rate, skin conductance) are continuously measur...
Secondary outcomes (1)
Secondary measures include the Mood form, assessed at baseline and after each cue, and measures of the virtual reality experience including the Immersion Questionnaire and Imagery Realism Presence Questionnaire, administered following the sessio...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study start26 Sep 2010
- Study completion26 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen J Heishman, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212081
- Sponsor's protocol ID
- 999910462
- Other IDs
- 10-DA-N462
- Status last verified
- 26 Nov 2012
- First submitted
- 29 Sep 2010
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Addington J, Addington D. Patterns, predictors and impact of substance use in early psychosis: a longitudinal study. Acta Psychiatr Scand. 2007 Apr;115(4):304-9. doi: 10.1111/j.1600-0447.2006.00900.x.
PubMed 17355521Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
PubMed 7165477Bordnick PS, Graap KM, Copp H, Brooks J, Ferrer M, Logue B. Utilizing virtual reality to standardize nicotine craving research: a pilot study. Addict Behav. 2004 Dec;29(9):1889-94. doi: 10.1016/j.addbeh.2004.06.008.
PubMed 15530734
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cannabis Craving in Schizophrenia Using Virtual Reality
- ClinicalTrials.gov ID
- NCT01212081
- Acronym / sponsor ID
- 999910462
- Conditions
- Cannabis Use
- Keywords
- Virtual Reality, Schizophrenia, Cannabis, Assessment, Craving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 26 Sep 2010
- Study completion
- 26 Nov 2012
- First posted
- 30 Sep 2010 (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.
Background:
- Individuals with schizophrenia or schizoaffective disorders have a high prevalence of cannabis use. Understanding some of the environmental factors that maintain cannabis use, such as socially triggered cravings, is a critical step in improving treatment for cannabis dependence. In recent years, virtual reality has been studied to determine whether it can be used to induce craving by using life-like cue settings. Researchers are interested in using virtual reality systems to study cannabis cravings in individuals with schizophrenia.
Objectives:
- To determine if virtual reality cues will elicit cannabis craving in persons with schizophrenia who have a history of cannabis use.
Eligibility:
- Individuals between 18 and 50 years of age who have been diagnosed with schizophrenia or schizoaffective disorders, are on a stable antipsychotic medication, and who have a lifetime history of at least 50 cannabis uses and average cannabis use of once per month.
Design:
- This study involves an initial screening visit, a study visit, and a followup visit.
- Participants will be screened with a medical history and physical examination, and will complete questionnaires about their history of marijuana and other drug use. Participants will also learn how to use the virtual reality equipment at this visit.
- During the study visit, participants will respond to marijuana cues using the virtual reality system while researchers monitor their heart rate, blood pressure, and sweat levels.
- At the followup visit, participants will complete questionnaires about their mood and any cravings for marijuana.
Detailed description
Objective: The use of cannabis is prevalent in people with schizophrenia, and has been linked both to onset of illness and worsening of symptoms. Craving in persons with schizophrenia who use cannabis has not been widely studied. The occurrence of craving may lead to relapse in substance use disorders. Therefore, craving paradigms in people with schizophrenia need to be optimized in order to test new treatments on craving measures in this population. Thus, the purpose of this study is to determine the feasibility and effects of virtual reality cues on craving intensity for cannabis in patients with schizophrenia
Study population: We will enroll 25 persons with a DSM IV diagnosis of schizophrenia who have a lifetime history of at least 50 lifetime uses of cannabis and cannabis use an average of at least once per month (or, if inpatients, average use of once per month prior to hospitalization) with a goal of 16 completers.
Design: This study uses a comparison-controlled, within-subject design. All subjects will undergo a baseline assessment and acclimation period and then participate in an experimental condition in which four cues will be presented in separate rooms in the VR program. These include two cannabis cues and two neutral cues in four different rooms. A follow up session for craving and symptom assessments will occur one week after the experimental session.
Outcome Measures:
At the end of each of the four cues, the Cannabis Craving Scale (CCVAS), Cannabis Attention scale (CAS), the Marijuana Craving Questionnaire-Short Form (MCQ-SF), and a visual analog cigarette craving item will be administered to measure craving during the virtual reality session. The CCVAS and CAS will be projected into the VR environment and participants will respond via hand controller. The MCQ-SF will also be administered, as well as the Mood form , to assess mood, at baseline as well as at the end of each of the 4 cues. Before and after the experimental session participants will also be rated on the Brief Psychiatric Rating Scale (BPRS), Schedule for the Assessment of Negative Symptoms (SANS), side effects, and the State-Trait Anxiety Inventory (STAI). The Immersion Questionnaire and Imagery Realism Presence Questionnaire (PQ) will be given at the conclusion of the experimental session. Before and after the session, as well as during the experiment participants will be monitored for physiological reactivity (heart rate, blood pressure, and skin conductance response) to cues of cannabis use as well as neutral cues measured.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-55 year old males and females
- Lifetime history of at least 50 cannabis uses and average cannabis use of once per month (or average use of once per month prior to hospitalization, if inpatient)
- Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Stable antipsychotic regimen (4 weeks on antipsychotic regimen and 30 days at current dose)
- Medically healthy as determined by screening criteria
Key exclusion criteria (5 listed)
- DSM-IV diagnosis of active alcohol or substance abuse (besides cannabis or nicotine) 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 MAI (dronabinol, varenicline, bupropion, etc)
- History of head injury, seizures, stroke, or severe motion sickness
- Positive urine toxicology screen for agents besides cannabis for substances other than cannabis or those used for therapeutic purposes: Participants who have an initial positive urine toxicology screen for substances other than those used for therapeutic purposes or cannabis 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.
- Positive pregnancy test (if female)
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
Primary measures include the Cannabis Craving Scale, Cannabis Attention Scale, and Marijuana Craving Questionnaire-Short Form, assessed after each cue. Physiological measures (blood pressure, heart rate, skin conductance) are continuously measur...
1 secondary outcome
Secondary measures include the Mood form, assessed at baseline and after each cue, and measures of the virtual reality experience including the Immersion Questionnaire and Imagery Realism Presence Questionnaire, administered following the sessio...
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 5 Apr 2018.
- Background: PubMed 17355521Addington J, Addington D. Patterns, predictors and impact of substance use in early psychosis: a longitudinal study. Acta Psychiatr Scand. 2007 Apr;115(4):304-9. doi: 10.1111/j.1600-0447.2006.00900.x.
- Background: PubMed 7165477Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
- Background: PubMed 15530734Bordnick PS, Graap KM, Copp H, Brooks J, Ferrer M, Logue B. Utilizing virtual reality to standardize nicotine craving research: a pilot study. Addict Behav. 2004 Dec;29(9):1889-94. doi: 10.1016/j.addbeh.2004.06.008.
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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.
Stephen J Heishman, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Cannabis Use, run by National Institute on Drug Abuse (NIDA) 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 6 inclusion and 5 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 5 Apr 2018. 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?
Primary measures include the Cannabis Craving Scale, Cannabis Attention Scale, and Marijuana Craving Questionnaire-Short Form, assessed after each cue. Physiological measures (blood pressure, heart rate, skin conductance) are continuously measur.... It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212081, which also lists 3 linked publications.
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 5 Apr 2018.