NCT00438139

Brief Summary

The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 16, 2017

Status Verified

February 1, 2007

Enrollment Period

Same day

First QC Date

February 20, 2007

Last Update Submit

January 13, 2017

Conditions

Marijuana Dependence

Keywords

marijuana dependence

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular responses

Interventions

DronabinolDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be between the ages of 18 to 45 years of age
  • Must be in good general health
  • Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study
  • Must be able to provide written informed consent
  • Must be able to provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
  • If female and of child bearing potential, must agree to use birth control.

You may not qualify if:

  • Criteria:
  • Please contact site for more information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of Health Science

Bethesda, Maryland, 20814 4799, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Louis Cantilena, M.D.

    Uniformed Services University of Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 16, 2017

Record last verified: 2007-02

Locations

US(1)