NCT00241592

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2004

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

June 14, 2007

Status Verified

June 1, 2007

First QC Date

October 18, 2005

Last Update Submit

June 12, 2007

Conditions

Healthy Volunteers

Keywords

CannabisMarijuanaVaporizationVolcanoTHC

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

CannabisDRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Community Consortium

San Francisco, California, 94110, United States

Location

Related 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. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.

    PMID: 17429350RESULT

Related Links

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Donald I Abrams, M.D.

    UCSF Community Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

August 1, 2004

Study Completion

May 1, 2005

Last Updated

June 14, 2007

Record last verified: 2007-06

Locations

US(1)