Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263181140
Study information
Scientific title
Acronym
Study hypothesis
Are the transient psychotic like effects induced by delta-9-tetrahydrocannibinol correlated with excess dopamine release in the striatum as measures by (123I)-IBZM single photon emission tomography (SPET)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mental and Behavioural Disorders: Psychosis
Intervention
1. THC drug
2. Placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Cannabis
Primary outcome measure
1. The percentage decrease in specific (123I)-IBZM binding under THC vs placebo conditions
2. The relationship between THC induced PANSS increases and (123I)-IBZM displacement
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2006
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
External patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Nuclear Medicine
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list