Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection

Healthy Clinical Trial

Official title:

Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534716
• Other study ID #: KEK-33/07
• Status: Completed
• Phase: N/A
• First received: September 24, 2007
• Last updated: May 6, 2008
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Federal Office of Sports, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	Clinical Investigation Unit (CIU), University Hospital ("Inselspital")	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Federal Office of Sports, Switzerland

Country where clinical trial is conducted

Switzerland,