Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection
Study Details
Study Description
Brief Summary
The purpose of this study on volunteers is whether THC and short-living metabolites are suited to detect recent Cannabis smoking within urine doping control.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
About half of all positive doping cases in Switzerland have been related to Cannabis consumption (mainly recreational smoking). So far, the target analyte in urine is 11-nor-9-carboxy-THC (THC-COOH), the main metabolite of delta-9-tetrahydrocannabinol (THC), which is excreted up to several days after single use. However, the wide detection window of THC-COOH does not allow a conclusion concerning the impact on the physical performance. Therefore, the evaluation of other target analytes with shorter elimination half-lives is needed and the aim (primary endpoints) of the present study. This pharmacokinetic, open, 1-session trial on 12 healthy, male, infrequently Cannabis smoking volunteers is focussed on the GC/MS profiling of THC and metabolites in urine and plasma after standardized smoking of a single 7% THC Cannabis cigarette of the Dutch Ministry of Health, Welfare & Sport, Office of Medicinal Cannabis. Pharmacodynamic measurements (secondary endpoints) include the side-effects monitoring by using Visual Analog Scales and checking vital functions.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male subjects; light (max. 1/month), infrequent Cannabis smokers, medium (max. 15/month) tobacco smokers experienced in the inhalation technique; age 20-30 years; body weight 75+/-15 kg; evaluation based on normal medical history, physical examination, laboratory tests (safety lab), normal lung functions (spirometry).
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Informed consent after information (written) by the study physician and principal investigator on nature, significance and scope of the trial.
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Informed consent by the volunteer regarding transmitting trial-related data to the sponsor and to the competent control authorities.
Exclusion Criteria:
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Hypersensitivity to cannabinoids. - Regular (more than once per month, weekly or daily) Cannabis use. - The use of alcohol, any medication or drugs, especially Cannabis, within the last 2 days prior to and during the 1-day session is not allowed. Cannabis use is also not allowed during the following 11 days of urine collection, i.e. up to the end of the study.
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Positive Cannabis urine test before the session.
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Driving any vehicle, and operating with machines during and within 48 h after the session.
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Psychotic or vulnerable subjects.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Investigation Unit (CIU), University Hospital ("Inselspital") | Bern | Switzerland | CH-3010 |
Sponsors and Collaborators
- Federal Office of Sports, Switzerland
Investigators
- Principal Investigator: Rudolf Brenneisen, PhD, Prof, University of Bern, Dept. Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KEK-33/07