NCT00217971

Brief Summary

The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 1, 2011

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

4.8 years

First QC Date

September 16, 2005

Results QC Date

September 13, 2011

Last Update Submit

April 22, 2019

Conditions

Marijuana Abuse

Keywords

cannabis dependencedronabinoltreatment

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial

    Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.

    weeks 7 and 8

Study Arms (2)

Dronabinol

ACTIVE COMPARATOR

Dronabinol: 20mg bid for a daily maximum dose of 40mg.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

DronabinolDRUG

Dronabinol

Also known as: Marinol
Dronabinol
PlaceboDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men and women between the ages of 18-60
  • Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse
  • Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry
  • Individuals must be capable of giving informed consent and capable of complying with study procedures.
  • Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.

You may not qualify if:

  • History of seizures
  • Known sensitivity to dronabinol
  • Unstable medical conditions
  • Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
  • Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
  • Pregnant or breast-feeding
  • Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation.
  • Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms.
  • Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP \> 150, DBP\> 90, or HR \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \< 2-3X upper limit of normal are acceptable), or medically unstable diabetes.
  • Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter).
  • Individuals who are court-mandated to treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Foundation for Mental Hygiene, Inc.

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Limitations and Caveats

Consequences of use are often long-term and more subtle. Thus, trying to initiate change over a relatively short period (i.e. patients in the present trial were maintained on the maximum dronabinol dose for only 6 weeks), may have been inadequate.

Results Point of Contact

Title
Frances R. Levin, M.D.
Organization
Columbia University
frl2@columbia.edu
(212) 543-5896

Study Officials

  • Frances R Levin, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Substance Use Disorder

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 24, 2019

Results First Posted

November 1, 2011

Record last verified: 2019-04

Locations

US(1)