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Vulnerability markers in the association between cannabis and schizophrenia

Vulnerability markers in the association between cannabis and schizophrenia: a randomised controlled trial of acute cannabinoid administration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24109245
Enrollment
40
Registered
2012-11-19
Start date
2012-11-12
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis use and psychosis Mental and Behavioural Disorders Mental and behavioural disorders due to use of cannabinoids

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. Tetrahydrocannabi

Sponsors

University of Wollongong (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The effect of THC and CBD on MMN amplitude recorded immediately following drug administration

Secondary

MeasureTime frame
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.

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026