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

September 9, 2005
December 2, 2009
November 2004
July 2005   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00167297 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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Atomoxetine for the Treatment of Cannabis Dependence
A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cannabis Dependence
Drug: Atomoxetine
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.
Intervention: Drug: Atomoxetine
Tirado CF, Goldman M, Lynch K, Kampman KM, Obrien CP. Atomoxetine for treatment of marijuana dependence: a report on the efficacy and high incidence of gastrointestinal adverse events in a pilot study. Drug Alcohol Depend. 2008 Apr 1;94(1-3):254-7. Epub 2008 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2005
July 2005   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167297
801701, P60DA005186-17, T32MH019126-14, T32MH019126-15, T32MH019126-16
No
Kyle Kampman, M.D., University of Pennsylvania, Treatment Reseach Center
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Principal Investigator: Carlos F. Tirado, M.D. University of Pennsylvania
National Institute on Drug Abuse (NIDA)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP