Vaporization as a Smokeless Cannabis Delivery System

Healthy Volunteers Clinical Trial

Official title:

Vaporization as a Smokeless Cannabis Delivery System: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241592
• Other study ID #: C03-SF-115
• Secondary ID: CC#062CHR# 105-2
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2005
• Last updated: June 12, 2007
• Start date: August 2004
• Est. completion date: May 2005

Study information

• Verified date: June 2007
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cannabis

Locations

Country	Name	City	State
United States	UCSF Community Consortium	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. Epub 2007 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Center for Medicinal Cannabis Research