Ph1 Marinol Interaction Study - Part 2 - 1
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
1 other identifier
interventional
12
1 country
1
Brief Summary
This study will 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 drug interactions before conducting outpatient studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
April 8, 2013
CompletedJanuary 12, 2017
August 1, 2016
1.2 years
June 21, 2007
December 19, 2012
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.
Day 9 and 10
Study Arms (2)
Dronabinol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Must be between 18 and 45 years of age
- Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence
- Must be seeking treatment at time of study entry
- Must be able to understand and provide written informed consent
- Must provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
- If female and of child bearing potential, agrees 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lou Cantelina
- Organization
- Uniformed Services University for the Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Cantilena, M.D.
Uniformed Services University of Health Science
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- NIDA Project Officer
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 22, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 12, 2017
Results First Posted
April 8, 2013
Record last verified: 2016-08