Atomoxetine for the Treatment of Cannabis Dependence

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this small open-label trial is to evaluate the feasibility of recruiting cannabis dependent patients for treatment with Atomoxetine and MIT. The clinical data to date on Atomoxetine has been limited to children and adults with attention deficit disorder without co-morbid substance dependence. However, one study estimated that adults with attention deficit disorder have rates of drug abuse three to four times higher than controls (Mannuzza S 1998). The study also reported that cannabis and cocaine are most frequently abused in this population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborator: University of Pennsylvania
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Males and females, 18-65 years old

• Meets DSM-IV criteria for Cannabis Dependence

• Live within a commutable distance of the Treatment Research Center

• Understands and signs the informed consent

Exclusion Criteria:

• Current DSM-IV diagnosis of any psychoactive substance dependence other than marijuana, or nicotine dependence

• History of a learning disability

• History of a diagnosis of ADHD made by a psychiatrist.

• Concomitant treatment with psychotropic medications, especially Monoamine Oxidase Inhibitors

• Mandated to treatment based upon a legal decision or as a condition of employment

• Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which could make it unsafe for the patient to participate in the opinion of the primary investigators.

• Use of any investigational medication within the past 30 days

• Current treatment with pressor agents or albuterol.

• History of narrow angle glaucoma.

• History of significant, unstable heart disease, including myocardial infarction, unstable angina, cardiac failure, second or third degree heart block, or uncontrolled hypertension

• Known hypersensitivity to atomoxetine

• Subjects with known AIDS or other serious illnesses, which may require hospitalization during the study

• Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:

Barrier (diaphragm or condom) with spermicide Intrauterine device Levonorgestrel implant Medroxyprogesterone acetate contraceptive injection Oral contraceptives

-Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the principal investigators. On EKG, 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed. Liver function tests (LFT's) <5 times ULN without symptoms of liver disease are acceptable after thorough medical review.