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Atomoxetine for the Treatment of Cannabis Dependence

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00167297
First received: September 9, 2005
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cannabis Dependence
 Drug: Atomoxetine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Marijuana use in patients treated with atomoxetine and Motivational Interviewing Therapy measured using weekly urine drug screens. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of atomoxetine: Tolerability will be assessed by examining the rates of certain adverse events during the treatment phase. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: November 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atomoxetine
Atomoxetine (Strattera) 25mg peroral (PO) each day for seven days, then up to 40mb bid 40mg PO each day for three days, then 80mg PO bid.
 Drug: Atomoxetine

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167297

Locations
United States, Pennsylvania
University of Pennsylvania Treatment Rersearch Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Investigators
Principal Investigator: Carlos F. Tirado, M.D. University of Pennsylvania
  More Information

Publications:

Responsible Party: Kyle Kampman, M.D., University of Pennsylvania, Treatment Reseach Center
ClinicalTrials.gov Identifier: NCT00167297     History of Changes
Other Study ID Numbers: 801701, P60DA005186-17, T32MH019126-14, T32MH019126-15, T32MH019126-16
Study First Received: September 9, 2005
Last Updated: December 2, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
atomoxetine
cannabis dependence
treatment

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013