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

NCT00534716 | Completed DMC

• 1 other identifier: KEK-33/07
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cannabis; doping; THC; GC/MS; Pharmacokinetics; Volunteers

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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, normal medical history physical examination, passed laboratory tests (safety lab), normal lung functions (spirometry).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Office of Sports, Switzerland: lead

Study Sites (1)

Clinical Investigation Unit (CIU), University Hospital ("Inselspital")

Bern, CH-3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, urine

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rudolf Brenneisen, PhD, Prof

  University of Bern, Dept. Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2008
• Last Updated: May 12, 2008

Record last verified: 2008-05

Locations

CH (1)