Effects of Dronabinol (Oral THC) on Cannabis Use

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01394185
First received: July 12, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. This research is designed to determine whether the FDA approved medication dronabinol (Marinol®) has effects that might help make it easier for people to stop daily marijuana use, and to carefully study the occurence of safety risks and side-effects at different doses of the drug.


Condition Intervention Phase
Marijuana Smoking
Drug: Dronabinol
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dronabinol (Oral THC) on Cannabis Use

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Marijuana self-administration [ Time Frame: up to 39-day hospital stay ] [ Designated as safety issue: No ]
    Participants will be able to self-administer marijuana under different study conditions. The amount administered across these conditions is the primary study endpoint


Secondary Outcome Measures:
  • Drug effect [ Time Frame: Measured daily during 39-day hospital stay ] [ Designated as safety issue: Yes ]
    Participants will complete assessments regarding subjective drug effects multiple times each day.

  • Vitals [ Time Frame: Measured daily during 39-day hospital stay ] [ Designated as safety issue: Yes ]
    Participants will have vitals assessed multiple times each day.


Enrollment: 25
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dronabinol
Participants receive active dronabinol
Drug: Dronabinol
Participants receive dronabinol
Other Names:
  • Marinol
  • THC
Placebo Comparator: Placebo
Participants receive placebo
Drug: Placebo
Participants receive placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current use of marijuana
  • Able to give informed consent

Exclusion Criteria:

  • Daily use of psychoactive medication
  • Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
  • Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
  • Uncontrolled or unstable cardiovascular disease
  • Allergy to sesame oil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394185

Locations
United States, Maryland
Johns Hopkins University (Bayview Campus)
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Ryan Vandrey, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01394185     History of Changes
Other Study ID Numbers: NA_00041251, R01DA025044
Study First Received: July 12, 2011
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
marijuana
dronabinol
pharmacotherapy

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

ClinicalTrials.gov processed this record on October 01, 2014