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Trial record 47 of 1820 for:    NIDA

Ph1 Marinol Interaction Study - Part 1 - 1

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ClinicalTrials.gov Identifier: NCT00438139
Recruitment Status : Terminated
First Posted : February 21, 2007
Last Update Posted : January 16, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Marijuana Dependence Drug: Dronabinol Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol




Primary Outcome Measures :
  1. Cardiovascular responses


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 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.

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): NCT00438139


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

Responsible Party: Liza Gorgon, NIDA
ClinicalTrials.gov Identifier: NCT00438139     History of Changes
Other Study ID Numbers: NIDA-CPU-0011-1
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: February 2007

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

Additional relevant MeSH terms:
Marijuana Abuse
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
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists