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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217971
Other study ID # #4886-NIDA-09236-11
Secondary ID P50DA009236P50DA
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2005
Est. completion date December 2009

Study information

Verified date April 2019
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dronabinol
Dronabinol
Placebo
placebo

Locations

Country Name City State
United States Research Foundation for Mental Hygiene, Inc. New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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