Dronabinol Treatment for Marijuana Addiction (MARINOL)

New York State Psychiatric Institute

Status and phase

Completed

Phase 2

Conditions

Marijuana Abuse

Treatments

Drug: Dronabinol

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00217971

#4886-NIDA-09236-11

P50DA009236-11 (U.S. NIH Grant/Contract)

DPMC

P50DA009236 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

156 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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.