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Acceptance of two variants of medical cannabis by psychotic patients: a randomised cross-over study (N=12).

Acceptance of two variants of medical cannabis by psychotic patients: a randomised cross-over study (N=12). - Acceptance of medical cannabis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44002
Enrollment
12
Registered
2016-11-04
Start date
2016-12-13
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

hallucinations schizophrenia

Interventions

12 patients receive frpm the investigator in total 4 joints (two with Bediol and two with Bedrobinol) that they smoke in the presence of the researcher on four different days.
Cannabis
Psychosis
Schizophrenia
Side effects

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. males aged 18 to 65 2. At present (almost) daily (at least 4-5 times a week) use of Dutch weed (cannabis containing THC virtually only) 3. Chronic psychotic disorder and is currently in a treatment / care program 4. According to the practitioner a suboptimal response to currently available interventions, eg, persistent psychotic symptoms, psychotic decompensations frequent and / or severe impairment in social functioning 5. Willing to smoke two medicinal cannabis variants that differ in THC / CBD ratio. On four different days one joint is smoked (two joints a variant, a total of 4 joints).

Exclusion criteria

Exclusion criteria: 1. suffering from a serious neurological or medical illness (other than schizophrenia) 2. heavy use of alcohol (> 60 gram per day) or regular use (> 2x per week) of amphetamine, cocaine or opiates

Design outcomes

Primary

MeasureTime frame
The primary question is whether the participant cannabis version with 8% CBD (Bediol) from the drop wants to smoke rather than by himself so far purchased cannabis variety. Question 1. Would you take this cannabis in the sequel as a preferred alternative? Question 2. If yes. Is this because of fewer side effects when smoking this variant or other reasons?

Secondary

MeasureTime frame
1. Experience with the cannabis just smoked (enough *high*, taste)? Different or similar to the kind you smoke normally? 2. Experiences during/after smoking the joints (less anxiety, panic, calm, drowsiness, excited, pleasant, stoned, dizziness, restlessness, lethargic, depressed or lethargic feeling, craving, sweating, nausea, dizziness, tremors, palpitations (Questionnaires see F9 + F10).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)