Vaporization as a Smokeless Cannabis Delivery System

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00241592
First received: October 18, 2005
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.


Condition Intervention Phase
Healthy Volunteers
Drug: Cannabis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Vaporization as a Smokeless Cannabis Delivery System: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:
  • To assess the delivery of cannabinoids and metabolites by way of vaporization and to compare plasma levels to those obtained from smoking an identical amount of marijuana from a cigarette.

Estimated Enrollment: 18
Study Start Date: August 2004
Estimated Study Completion Date: May 2005
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 (THC), cannabinol, cannabidiol, and metabolites, including 11-OH-THC, in healthy volunteers after smoking ~400 mg each of approximately 1.8, 3.5, and 7% THC marijuana cigarettes (using the Foltin puff procedure) to those obtained when the same individuals inhale the vaporization product of the rest of the marijuana from the identical cigarette processed through the Volcano device. In addition to plasma levels, we will also compare the THC concentrations over an 8-hour time period, the subjective high experienced by the patients, and clinical evidence of cannabis effect by evaluating conjunctival hyperemia and heart rate. We will also compare the tolerability of the two methods of ingestion, and we will monitor expired carbon monoxide to evaluate whether the vaporizer reduces exposure to respiratory toxins.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241592

Locations
United States, California
UCSF Community Consortium
San Francisco, California, United States, 94110
Sponsors and Collaborators
Center for Medicinal Cannabis Research
University of California, San Francisco
Investigators
Principal Investigator: Donald I Abrams, M.D. UCSF Community Consortium
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00241592     History of Changes
Other Study ID Numbers: C03-SF-115, CC#062, CHR# 105-22909-02, PR# 0334
Study First Received: October 18, 2005
Last Updated: June 12, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
Cannabis
Marijuana
Vaporization
Volcano
THC

ClinicalTrials.gov processed this record on October 21, 2014