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Ph1 Marinol Interaction Study - Part 2 - 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liza Gorgon, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00490269
First received: June 21, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Dronabinol
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Liza Gorgon, NIDA Project Officer, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00490269     History of Changes
Other Study ID Numbers: NIDA-CPU-0013-1
Study First Received: June 21, 2007
Results First Received: December 19, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013