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Ph1 Marinol Interaction Study - Part 2 - 1

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ClinicalTrials.gov Identifier: NCT00490269
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : April 8, 2013
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
, National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE June 21, 2007
First Posted Date  ICMJE June 22, 2007
Results First Submitted Date  ICMJE December 19, 2012
Results First Posted Date  ICMJE April 8, 2013
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. [ Time Frame: Day 9 and 10 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
Cardiovascular responses
Change History Complete list of historical versions of study NCT00490269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph1 Marinol Interaction Study - Part 2 - 1
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Marijuana Dependence
Intervention  ICMJE
  • Drug: Placebo
    Other Name: Placebo comparator arm
  • Drug: Dronabinol
    Other Name: Medication intervention
Study Arms  ICMJE
  • Active Comparator: Dronabinol
    Intervention: Drug: Dronabinol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2007)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion

Criteria:

  • Please contact site for more information
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00490269
Other Study ID Numbers  ICMJE NIDA-CPU-0013-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party , National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP