Status:
COMPLETED
Atomoxetine for the Treatment of Cannabis Dependence
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Cannabis Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a Phase 2 open-label study. We will recruit 10 cannabis dependent subjects and treat them with the combination of Atomoxetine and MIT to reduce their consumption of cannabis. Subjects will be ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00167297
Start Date
November 1 2004
End Date
July 1 2005
Last Update
January 11 2017
Active Locations (1)
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1
University of Pennsylvania Treatment Rersearch Center
Philadelphia, Pennsylvania, United States, 19104