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van CCT (UK)

van CCT (UK)

Alcohol and cannabis.

- candidate number5892
- NTR NumberNTR1840
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2009
- Secondary IDs09-3-018 MEC MUMC
- Public TitleAlcohol and cannabis.
- Scientific TitleA study into the combined effects of alcohol and cannabis on cognitive performance in high experienced cannabis users.
- hypothesisIt is hypothesized that in the population of frequent cannabis users, cross tolerance will have developed for the effects of alcohol, and that therefore the behavioral effects after alcohol will be less when given in combination with cannabis.
- Healt Condition(s) or Problem(s) studiedCannabis, Cognitive functions
- Inclusion criteria1. Free from psychotropic medication;
2. Good physical health as determined by medical examination and laboratory analysis (Appendix 1);
3. Absence of any major medical, endocrine and neurological condition;
4. Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2;
5. Written Informed Consent;
6. To check whether subjects are high experienced users, a blood sample from the screening will be tested. THC in blood has to be >= 3,5 ng/ml;
7. Participants are smokers with a maximum of 25 cigarettes/day.
- Exclusion criteria1. History of drug abuse or addiction (other than the use of cannabis);
2. Pregnancy or lactation;
3. Excessive drinking (> 21 alcoholic consumptions a week);
4. No experience with alcohol;
5. Excessive smoking (>25 cigarettes/day);
6. Hypertension (diastolic> 100; systolic> 170);
7. Current or history of psychiatric disorder;
8. Color-blindness;
9. Dyslexia.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate31-jan-2010
- Target number of participants21
- InterventionsCannabis (400 g/kg bodyweight THC) in combination with alcohol to reach 0,0, 0,5 and 0,8 mg/ml BAC.
- Primary outcomeTo determine the pharmacokinetic and pharmacodynamic parameters of THC in combination with alcohol as a function of time.
- Secondary outcomeN/A
- TimepointsThe test battery will be repeated three times, up to 7 hours after alcohol administration and 4 hours after cannabis smoking.
Pharmacokinetic samples will be taken app. every 30 minutes after cannabis smoking.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryIn this study we will investigate whether there is cross tolerance for the effects of alcohol and cannabis. Therefore we will investigate both the pharmacodynamic and pharmacokinetic effects of a combined administration of cannabis and alcohol. Randomized, double-blind, placebo controlled, 3-way cross-over design.
1. 21 volunteers, age between 18 and 40, will be randomly assigned to a treatmentorder;
2. There are 3 test days in this study, on which the subject will be administered alcohol. After this the alcohol level will be kept constant by giving small repeated doses of alcohol. 2,5 hours after the first alcohol administration, the cannabis sigaret will be smoked. In between test days, there will be a wash out period of at least 7 days;
3. Before inclusion, a medical screening will take place. Also a training of the different tests will take place;
4. On each test day different cognitive test will be administered to the subjects. A first time after administration of alcohol, and two times after smoking the cannabis sigaret. Furthermore, 11 blood samples and 12 saliva samples will be taken at different times during each test day.
- Main changes (audit trail)
- RECORD5-jun-2009 - 30-sep-2009

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