NCT01394185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 3, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

July 12, 2011

Results QC Date

April 18, 2017

Last Update Submit

August 2, 2017

Conditions

Marijuana Smoking

Keywords

marijuanadronabinolpharmacotherapy

Outcome Measures

Primary Outcomes (2)

  • 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

    12-day Dronabinol maintenance period

  • 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

    12-day Dronabinol maintenance period

Study Arms (1)

Low Dose Dronabinol, High Dose Dronabinol, and placebo

ACTIVE COMPARATOR

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

Drug: Dronabinol 120mg/dayDrug: PlaceboDrug: Dronabinol 240mg/day

Interventions

Dronabinol 120mg/dayDRUG

Participants receive 40mg dronabinol 3 times daily

Also known as: Marinol, THC
Low Dose Dronabinol, High Dose Dronabinol, and placebo
PlaceboDRUG

Participants receive placebo

Low Dose Dronabinol, High Dose Dronabinol, and placebo
Dronabinol 240mg/dayDRUG

Participants receive 80mg dronabinol 3 times daily

Also known as: Marinol, THC
Low Dose Dronabinol, High Dose Dronabinol, and placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current use of marijuana
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University (Bayview Campus)

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana SmokingMarijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Marijuana UseBehaviorSmoking, Non-Tobacco ProductsSmokingSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ryan Vandrey
Organization
Johns Hopkins University
rvandrey@jhmi.edu
410-550-4036

Study Officials

  • Ryan Vandrey, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 3, 2017

Results First Posted

August 3, 2017

Record last verified: 2017-08

Locations

US(1)