NCT01212081

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2012

Completed
Last Updated

April 5, 2018

Status Verified

November 26, 2012

First QC Date

September 29, 2010

Last Update Submit

April 4, 2018

Conditions

Keywords

Virtual RealitySchizophreniaCannabisAssessmentCraving

Outcome Measures

Primary Outcomes (1)

  • 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...

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue

Catonsville, Maryland, 21228, United States

Location

Related Publications (3)

  • 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.

    PMID: 17355521BACKGROUND
  • Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.

    PMID: 7165477BACKGROUND
  • Bordnick 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.

    PMID: 15530734BACKGROUND

MeSH Terms

Conditions

SchizophreniaMarijuana Abuse

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Stephen J Heishman, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

September 26, 2010

Study Completion

November 26, 2012

Last Updated

April 5, 2018

Record last verified: 2012-11-26

Locations