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Ph1 Marinol Interaction Study - Part 2 - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490269
First Posted: June 22, 2007
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
, National Institute on Drug Abuse (NIDA)
  Purpose
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.

Condition Intervention Phase
Marijuana Dependence Drug: Placebo Drug: Dronabinol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by , National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dronabinol Drug: Dronabinol
Other Name: Medication intervention
Placebo Comparator: Placebo Drug: Placebo
Other Name: Placebo comparator arm

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490269


Locations
United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science
  More Information

Responsible Party: , NIDA Project Officer, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00490269     History of Changes
Other Study ID Numbers: NIDA-CPU-0013-1
First Submitted: June 21, 2007
First Posted: June 22, 2007
Results First Submitted: December 19, 2012
Results First Posted: April 8, 2013
Last Update Posted: January 12, 2017
Last Verified: August 2016

Keywords provided by , National Institute on Drug Abuse (NIDA):
Marijuana dependence

Additional relevant MeSH terms:
Marijuana Abuse
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists