Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection
Information source: Federal Office of Sports, Switzerland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Phase: N/A
Status: Completed
Sponsored by: Federal Office of Sports, Switzerland Official(s) and/or principal investigator(s):
Rudolf Brenneisen, PhD, Prof, Principal Investigator, Affiliation: University of Bern, Dept. Clinical Research
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.
Clinical Details
Official title: Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions
Study design: Other, Prospective
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 30 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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).
- Informed consent after information (written) by the study physician and principal
investigator on nature, significance and scope of the trial.
- Informed consent by the volunteer regarding transmitting trial-related data to the
sponsor and to the competent control authorities.
Exclusion Criteria:
- 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.
- Positive Cannabis urine test before the session.
- Driving any vehicle, and operating with machines during and within 48 h after the
session.
- Psychotic or vulnerable subjects.
Locations and Contacts
Clinical Investigation Unit (CIU), University Hospital ("Inselspital"), Bern CH-3010, Switzerland
Additional Information
Starting date: September 2007
Ending date: May 2008
Last updated: May 6, 2008
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