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Vulnerability markers in the association between cannabis and schizophrenia
ISRCTN ISRCTN24109245
DOI 10.1186/ISRCTN24109245
ClinicalTrials.gov identifier
EudraCT number
Public title Vulnerability markers in the association between cannabis and schizophrenia
Scientific title Vulnerability markers in the association between cannabis and schizophrenia: a randomised controlled trial of acute cannabinoid administration
Acronym N/A
Serial number at source CT12/003
Study hypothesis The acute administration of cannabinoids (THC + CBD) will modulate the amplitude of the mismatch negativity (a brain marker of glutamate receptor function) in regular cannabis users versus non-naïve controls.
Lay summary Lay summary under review 2
Ethics approval Joint University of Wollongong and Illawarra and Shoalhaven Local Health Network Health and Medical Human Research Ethics committee, 6 August 2012, Reference number: CT12/003
Study design Randomised double-blind placebo-controlled crossover study
Countries of recruitment Australia
Disease/condition/study domain Cannabis use and psychosis
Participants - inclusion criteria Cannabis user group
1. Cannabis use for at least 3 years, and at least 4 times a month.
2. All participants must be between 18 and 55 years of age.

Control group
1. Cannabis use at least 5 times but less than 20 times in total across lifetime; and for those participants only having used 5-10 times, they must have used at least once in the last 2 years; while for those participants having used between 10 and 20 times, the most recent exposure must not have been more than 10 years ago. No cannabis use in the past 3 months.
2. All participants must be between 18 and 55 years of age.
Participants - exclusion criteria Cannabis user group
1. Daily cannabis use, or use of any illicit substance more than once a month for a period of six months
2. Head injury resulting in trauma to the brain, prolonged unconsciousness or concussion or required surgery, prolonged hospitalisation or rehabilitation
3. Medical diagnosis that would interfere with EEG testing (epilepsy, stroke, brain tumour, HIV positive, Hepatitis B or C, meningitis, encephalitis, MS, microcephaly), or a medical diagnosis contraindicated for cannabis exposure (e.g. asthma, cardiovascular disease, untreated hypertension).
4. Co-ingestion / concurrent use of medicines or drugs which will interfere with testing or are contraindicated for cannabis exposure (e.g. antipsychotics, antidepressants, benzodiazepines, amphetamines, opioids, alcohol).
5. A Body Mass Index (BMI) of less than 18 kg/m2 or more than 28 kg/m2.
6. A history of anaemia
7. Pregnancy
8. A current diagnosis of a psychotic disorder, or a score of 50 or more on the Community Assessment of Psychic Experiences. A first degree family member with psychotic diagnosis.
9. Use of any illicit substance (other than cannabis) in the 14 days prior to testing.
10. Meets DSM-IV criteria for dependence on alcohol or drugs other than cannabis; history of treatment for substance use problems other than cannabis.

Control group
1. Use of any illicit substance more than once a month for a period of six months.
2. Head injury resulting in trauma to the brain, prolonged unconsciousness or concussion or required surgery, prolonged hospitalisation or rehabilitation.
3. Medical diagnosis that would interfere with EEG testing (epilepsy, stroke, brain tumour, HIV positive, Hepatitis B or C, meningitis, encephalitis, MS, microcephaly), or a medical diagnosis contraindicated for cannabis exposure (e.g. asthma, cardiovascular disease, untreated hypertension).
4. Co-ingestion /concurrent use of medicines or drugs which will interfere with testing or are contraindicated for cannabis exposure (e.g. antipsychotics, antidepressants, benzodiazepines, amphetamines, opioids, alcohol).
5. A body Mass Index (BMI) of less than 18 kg/m2 or more than 28 kg/m2.
6. A history of anaemia.
7. Pregnancy
8. A current diagnosis of a psychotic disorder, or a score of 50 or more on the Community Assessment of Psychic Experiences.
9. A first degree family member with psychotic diagnosis. Use of any illicit substance (other than cannabis) in the 14 days prior to testing.
10. Meets DSM-IV criteria for dependence on alcohol or drugs or a history of treatment for substance use problems.
Anticipated start date 12/11/2012
Anticipated end date 31/03/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 40
Interventions Cannabis user and non-user non-naïve control participants will receive each of the following five conditions in randomised order, administered through a vaporiser

1. Tetrahydrocannabinol (THC) alone
2. Cannabidiol (CBD) alone (high dose)
3. THC+ CBD (low dose)
4. THC + CBD (high dose)
5. Placebo
Primary outcome measure(s) The effect of THC and CBD on MMN amplitude recorded immediately following drug administration
Secondary outcome measure(s) The effect of THC and CBD on
1. Other EEG/ERP measures including P50 and resting state EEG
2. Neuropsychological measures including CogState battery of tests
3. Psychotic-like symptoms as indicated on a visual analogue scale, the Psychotomimetic States Inventory and the Clinician Administered Dissociative States Scale.
4. The potential moderating effect of specific genetic polymorphisms on THC and CBD (alone and in combination) effects on the MMN and other EEG/ERP and neuropsychological measures.
Sources of funding National Health and Medical Research Council of Australia (NHMRC) (Australia) Project Grant ID: 1007593
Trial website
Publications
Contact name Dr  Nadia  Solowij
  Address School of Psychology
University of Wollongong
  City/town Wollongong
  Zip/Postcode 2522
  Country Australia
  Email nadia@uow.edu.au
Sponsor University of Wollongong (Australia)
  Address Northfields Avenue
  City/town Wollongong
  Zip/Postcode 2522
  Country Australia
Date applied 05/11/2012
Last edited 19/11/2012
Date ISRCTN assigned 19/11/2012
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