Expired Study
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New York, New York 10032


Purpose:

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


Study summary:

Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms. During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances. - 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.


Study is Available At:


Original ID:

#4886-NIDA-09236-11


NCT ID:

NCT00217971


Secondary ID:

P50DA009236


Study Acronym:

MARINOL


Brief Title:

Dronabinol Treatment for Marijuana Addiction


Official Title:

A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

156


Enrollment Type:

Actual


Overall Contact Information

Official Name:Frances R Levin, MD
Principal Investigator
New York State Psychiatric Institute

Study Dates

Start Date:March 2005
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 22, 2019
First Received Date:September 16, 2005
First Results Date:September 13, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
Time Frame:weeks 7 and 8
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Dronabinol
Description:Dronabinol
Arm Name:Dronabinol
Other Name:Marinol
Intervention Type:Drug
Name:Placebo
Description:placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:placebo
Study Arm Type:Active Comparator
Arm Name:Dronabinol
Description:Dronabinol: 20mg bid for a daily maximum dose of 40mg.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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