Atomoxetine 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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||November 2004|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167297
|United States, Pennsylvania|
|University of Pennsylvania Treatment Rersearch Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Carlos F. Tirado, M.D.||University of Pennsylvania|