HealthyNCT00534716
Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection
An observational study of Healthy, run by Federal Office of Sports, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Investigation Unit (CIU), University Hospital ("Inselspital")
Bern, CH-3010
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Cannabis, doping, THC, GC/MS, Pharmacokinetics, Volunteers
- Medical subject headings
- Marijuana Abuse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Office of Sports, Switzerland
- Sponsor type
- Other government
- Investigators
- Rudolf Brenneisen, PhD, Prof, Principal investigator, University of Bern, Dept. Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534716
- Sponsor's protocol ID
- KEK-33/07
- Status last verified
- May 2008
- First submitted
- 24 Sep 2007
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis and Doping - Pharmacokinetics of Smoked Cannabis Under Controlled Clinical Conditions
- ClinicalTrials.gov ID
- NCT00534716
- Acronym / sponsor ID
- KEK-33/07
- Conditions
- Healthy
- Keywords
- Cannabis, doping, THC, GC/MS, Pharmacokinetics, Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal Office of Sports, SwitzerlandOther government
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf Brenneisen, PhD, Prof principal investigator
University of Bern, Dept. Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Federal Office of Sports, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.