Effects of Dronabinol (Oral THC) on Cannabis Use

August 2, 2017 updated by: Johns Hopkins University
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University (Bayview Campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Dose Dronabinol, High Dose Dronabinol, and placebo
Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order
Drug: Dronabinol 120mg/day
Participants receive 40mg dronabinol 3 times daily
Other Names:
  • Marinol
  • THC
Drug: Placebo
Participants receive placebo
Drug: Dronabinol 240mg/day
Participants receive 80mg dronabinol 3 times daily
Other Names:
  • Marinol
  • THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marijuana Self-administration - Progressive Ratio
Time Frame: 12-day Dronabinol maintenance period
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
12-day Dronabinol maintenance period
Marijuana Self-administration - Drug Vs Money Choice
Time Frame: 12-day Dronabinol maintenance period
Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint
12-day Dronabinol maintenance period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Ryan Vandrey, Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00041251
  • R01DA025044 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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