Atomoxetine for the Treatment of Cannabis Dependence
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cannabis Dependence
Intervention: Atomoxetine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
Carlos F. Tirado, M.D., Principal Investigator, Affiliation: University of Pennsylvania
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.
Official title: A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 10 men and women with current DSM-IV diagnosis of cannabis dependence. All
patients will receive Atomoxetine and four sessions of MIT. The study length for each
patient will be one week for baseline screening and starting medication. This is followed
by 8 weeks of medication and an end of study visit one week after completing medications.
The PI will review all information collected regarding the subject's eligibility for the
study. The subject will return approximately four days later, and if the PI finds the subject
suitable for the study, the subject will begin taking study medication. This visit is
referred to as visit 2. During visit 2, the PI will monitor the subject for concomitant
medications and adverse events. The research technician will collect Vital Signs, Weight,
BAL, the TLFB, a Urine Tox Screen and THC/CR ratio. Both visits 1 and 2 will be conducted
within the first week of the study. Starting at visit 2, subjects will take one 25mg capsule
of Atomoxetine orally for seven days. Beginning at visit 3, subjects will increase the dose
to 40mg per day for 3 days, followed by 80mg (two 40mg capsules concurrently) for the other
four days of the second week. Beginning with week 3, subjects will take two 40mg capsules
(80mg total) every day of the week for 6 weeks.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- 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
- 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
- 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
- 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.
Locations and Contacts
University of Pennsylvania Treatment Rersearch Center, Philadelphia, Pennsylvania 19104, United States
Starting date: November 2004
Last updated: May 23, 2008