English: THC, haloperidol, psychosis, model, healthy volunteers, schizophrenia Dutch: THC, haloperidol, psychose, model, gezonde vrijwilligers, schizofrenie
Conditions
Interventions
All subjects received the treatment combinations ‘THC + placebo’ and ‘THC + haloperidol’ and half of the subjects received ‘haloperidol + placebo’ and the other half ‘placebo + placebo’.
Sponsors
See scientific contact
Zie contact wetenschappelijk
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers between 18 and 45 years of age; 2. Body Mass Index between 18 and 28.5 kg/m² inclusive; 3. Mild cannabis user for at least one year: cannabis use of no more than once a week (as an average in the last year), and able to refrain from using cannabinoids from at least 2 weeks prior to the first treatment period to the end of the follow-up period; 4. Volunteers are willing to give written informed consent to participate in the study and to comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Clinically significant (history of) major psychiatric illness or substance abuse; 2. Clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine, neurological and psychiatric disease as determined by medical history, physical examination, ECG or laboratory test results; 3. Congenital long QT syndrome in medical history; 4. Participation in a clinical study within 3 months preceding study, or participation in 4 or more trials in the past 12 months; 5. Positive urine screen for recreational drugs, i.e. cocaine, opioids, benzodiazepines, MDMA, metamphetamines, or amphetamines. THC will be tested as well. Since the volunteers are cannabis users and THC can be detected in the urine up to two weeks after cannabis use, subjects with a positive THC test at screening will be tested again and have to be found negative before the first study day. Subjects with a positive drug test, including THC, on a study day will be excluded; 6. Exposure to any medication, including over-the counter medications, 14 days prior to randomization (except paracetamol); 7. Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to screening; 8. Positive testing for Hepatitis B or C, or HIV 1-2; 9. Subject not able to refrain from alcohol from 24 hours before each study day until the end of the second study day; 10. Subject not able to refrain from smoking on study days; 11. Subject smokes more than 5 cigarettes per day; 12. Subject not able to refrain from xanthine intake on study days; 13. Subject not able to refrain from products containing quinine (bitter drinks in general) or grapefruit from 14 days prior to dosing until discharge; 14. Subject not able to refrain from exerting heavy physical exertion 24 hours before the study days; 15. Volunteers cannot participate if they have donated, including this study, more blood than allowed according to the regulations of the Dutch blood bank (Sanquin). Men are allowed to donate 500 ml of blood every three months; 16. Relevant (history of) drug allergy, history of hypersensitivity to drugs with a similar chemical structure as haloperidol; 17. Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive And Negative Symptoms Scale (PANSS): scores (negative, positive, and total scores). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scales from Bowdle for external effects (mm); 2. Visual Analogue Scales from Bond & Lader for subjective effects, and Bowdle for psychedelic effects (mm); 3. Saccadic eye movements: peak saccadic velocity (deg/s), saccadic latency (sec) and saccadic inaccuracy (%); 4. Smooth pursuit eye movements: average percentage of smooth pursuit for all stimulus frequencies the target (%); 5. Alpha Fz-Cz lead, Alpha Pz-Oz lead, Beta Fz-Cz lead, Beta Pz-Oz lead, Delta Fz-Cz lead, Delta Pz-Oz lead, Theta Fz-Cz lead, Theta Pz-Oz lead; 6. Body sway: antero-posteral sway (mm/2min); 7. Stroop: number correct and reaction time for correct answer both in basic and conflict situation; 8. VVLT: immediate word recall number correct (1st trial, 2nd trial, 3rd trial and average of 1st, 2nd, and 3rd trial), delayed word recall number correct, delayed word recognition (number correct and average reaction time correct); 9. LH, FSH, and cortisol concentrations; 10. Graphs and summary measures per treatment and time point for THC and metabolites and compartmental PK for THC. | — |
Contacts
Public ContactJ.M.A. Gerven, van
Center for Human Drug Research (CHDR), Zernikedreef 10
Outcome results
None listed