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Dronabinol Treatment for Marijuana Addiction (MARINOL)

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring cannabis dependence, dronabinol, treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dronabinol

Placebo

Arm Description

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

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00217971
Brief Title
Dronabinol Treatment for Marijuana Addiction
Acronym
MARINOL
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
cannabis dependence, dronabinol, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol
Arm Type
Active Comparator
Arm Description
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Other Intervention Name(s)
Marinol
Intervention Description
Dronabinol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
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.
Time Frame
weeks 7 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Click here for the Substance Treatment and Abuse Research Service (STARS) website

Learn more about this trial

Dronabinol Treatment for Marijuana Addiction

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