A double-blind, randomized, placebo-controlled, five-way cross-over interaction trial to investigate the inhibitory effect of olanzapine on a THC-induced increase on the Positive and Negative Syndrome Scale

Completed

Conditions: Psychosis
Psychotic disorder
10039628

Registration Number: NL-OMON33219

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• Male sex
• Age between 18 and 45 (extremes included)
• Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included)
• Mild cannabis user for at least one year, defined as use of cannabis no more than once a week (as an average in the last year)
• Ability to refrain from using cannabinoids (other than the THC used in the study) from at least two weeks prior to the first treatment period till the end of the follow-up periods
• Willing to give written informed consent to participate in the study and to comply with the study procedures

Exclusion Criteria

• Clinically significant (history of) psychiatric illness (including substance abuse)
• Clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine or neurological disease as determined by medical history, physical examination, ECG or laboratory test results
• Family history (first-degree relatives) of relevant psychiatric disorders and/or family history (second-degree relatives) of psychotic disorders
• Participation in a clinical study within the past three months
• Participation in four or more clinical studies in the past twelve months
• Positive urine screen for recreational drugs, i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, or MDMA. THC will be tested as well; since volunteers are cannabis users, subjects with a positive THC urine test will be tested again and have to be found THC-negative before the first study day. Subjects with a positive drug test on a study day, including THC, will be excluded
• Exposure to any medication, including over-the-counter medication and herbal agents, 14 days prior to randomization (except paracetamol)
• Exposure to prescription medication within 30 days prior to screening
• Positive testing for Hepatitis B or C, or HIV-1 or HIV-2
• Smokes more than four cigarettes per day
• Unable or unwilling to refrain from alcohol, starting 24 hours before each study day until the end of the study day
• Unable or unwilling to refrain from smoking on study days
• Unable or unwilling to refrain from xanthine (i.e. caffeine) intake on study days
• Unable or unwilling to refrain from quinine (bitter drinks in general, i.e. tonic, grapefruit juice) from 14 days before dosing until discharge
• Unable or unwilling to refrain from heavy physical exercise 24 hours before study days
• Unable or unwilling to maintain a regular day/night rhythm during the study
• Donation (or loss) of more blood, including this study, than allowed by the regulations of the Dutch blood bank (Sanquin)
• Relevant (history of) drug allergy or hypersensitivity to drugs
• Subject is the investigator or any sub-investigator, or a subordinate of the investigator or any sub-investigator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> - the PANSS (Positive and Negative Syndrome Scale - a widely used, clinical<br /><br>questionnaire based on a semi-structured interview)<br /><br>- Visual Analogue Scales (VAS - Bond & Lader, Bowdle - validated scales to<br /><br>objectify subjective parameters)</p><br>

Secondary Outcome Measures