Clinical trial NCT00217971: Dronabinol Treatment for Marijuana Addiction
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marijuana Abuse
Keywords: cannabis dependence
dronabinol
treatment
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
timeFrame: weeks 7 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Inc.
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Frances R Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: