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Effects of Dronabinol (Oral THC) on Cannabis Use

Primary Purpose

Marijuana Smoking

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dronabinol 120mg/day

Placebo

Dronabinol 240mg/day

About this trial

This is an interventional basic science trial for Marijuana Smoking focused on measuring marijuana, dronabinol, pharmacotherapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Johns Hopkins University (Bayview Campus)

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Low Dose Dronabinol, High Dose Dronabinol, and placebo

Arm Description

Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order

Outcomes

Primary Outcome Measures

Marijuana Self-administration - Progressive Ratio

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

Marijuana Self-administration - Drug Vs Money Choice

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01394185

First Posted

July 12, 2011

Last Updated

August 2, 2017

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01394185

Brief Title

Effects of Dronabinol (Oral THC) on Cannabis Use

Official Title

Effects of Dronabinol (Oral THC) on Cannabis Use

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Smoking

Keywords

marijuana, dronabinol, pharmacotherapy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose Dronabinol, High Dose Dronabinol, and placebo

Arm Type

Active Comparator

Arm Description

Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order

Intervention Type

Drug

Intervention Name(s)

Dronabinol 120mg/day

Other Intervention Name(s)

Marinol, THC

Intervention Description

Participants receive 40mg dronabinol 3 times daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants receive placebo

Intervention Type

Drug

Intervention Name(s)

Dronabinol 240mg/day

Other Intervention Name(s)

Marinol, THC

Intervention Description

Participants receive 80mg dronabinol 3 times daily

Primary Outcome Measure Information:

Title

Marijuana Self-administration - Progressive Ratio

Description

Time Frame

12-day Dronabinol maintenance period

Title

Marijuana Self-administration - Drug Vs Money Choice

Description

Time Frame

12-day Dronabinol maintenance period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Vandrey, Ph.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University (Bayview Campus)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

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Effects of Dronabinol (Oral THC) on Cannabis Use

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