Back to resultsPh1 Marinol Interaction Study - Part 1 - 1
Primary Purpose
Marijuana Dependence
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Sponsored by
About this trial
This is an interventional treatment trial for Marijuana Dependence focused on measuring marijuana dependence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion
Criteria:
- Please contact site for more information.
Sites / Locations
- Uniformed Services University of Health Science
Outcomes
Primary Outcome Measures
Cardiovascular responses
Secondary Outcome Measures
Full Information
NCT ID
NCT00438139
First Posted
February 20, 2007
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00438139
Brief Title
Ph1 Marinol Interaction Study - Part 1 - 1
Official Title
Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
marijuana dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Primary Outcome Measure Information:
Title
Cardiovascular responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion
Criteria:
Please contact site for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Cantilena, M.D.
Organizational Affiliation
Uniformed Services University of Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of Health Science
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814 4799
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ph1 Marinol Interaction Study - Part 1 - 1
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