- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534716
Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection
May 6, 2008 updated by: Federal Office of Sports, Switzerland
Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bern, Switzerland, CH-3010
- Clinical Investigation Unit (CIU), University Hospital ("Inselspital")
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rudolf Brenneisen, PhD, Prof, University of Bern, Dept. Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
September 24, 2007
First Submitted That Met QC Criteria
September 24, 2007
First Posted (Estimate)
September 26, 2007
Study Record Updates
Last Update Posted (Estimate)
May 12, 2008
Last Update Submitted That Met QC Criteria
May 6, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-33/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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