Status:
COMPLETED
Vaporization as a Smokeless Cannabis Delivery System
Lead Sponsor:
Center for Medicinal Cannabis Research
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-45 years
Phase:
PHASE1
Brief Summary
A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.
Detailed Description
Our primary objective is to evaluate the use of a vaporization system ( the Volcano) as a smokeless delivery system for inhaled marijuana. We will compare plasma levels of delta-9-tetrahydrocannabinol...
Eligibility Criteria
Inclusion
- Age 21-45 years Current history use of marijuana. Subjects must have smoked marijuana within the past 30 days but an amount totaling less than 10 marijuana cigarettes or the equivalent.
- All men and women in this study must agree to use adequate birth control during the study. Acceptable barrier birth control methods are a male condom, female condom, diaphragm, or intra-uterine (IUD).
- All women of reproductive potential (who have not reached menopause or undergone hysterectomy, oophorectomy,or tubal ligation) must have a negative urine B-HCG pregnancy test performed 48 hours before initiating the protocol-specified medication.
- Able to understand and follow the instructions of the investigator and research personnel.
- Able and willing to provide informed consent.
Exclusion
- Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, or orthostatic mean blood pressure drop greater than 24mm/Hg, severe chronic obstructive pulmonary disease.
- History of renal or hepatic failure. Evidence of hepatic, hematological or renal dysfunction based on judgement of physician.
- Active substance abuse. Marijuana dependence as defined in DSM-IV code#304.30. Any psychiatric dysfunction that would, in the opinion of the study investigator, interfere with a participant's ability to comply with the study protocol.
- Use of tobacco within the past 30 days. Subjects taking medications which may be vulnerable to drug-drug interactions such as those metabolized by the cytochrome P450 enzyme system.
- Blood donation in the past 30 days. Use of smoked marijuana within 48 hours of GCRC admission. Women who are pregnant or breast-feeding may not take part in this study. Unable to read or speak English.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00241592
Start Date
August 1 2004
End Date
May 1 2005
Last Update
June 14 2007
Active Locations (1)
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1
UCSF Community Consortium
San Francisco, California, United States, 94110