A Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
Objective of the Project.
-Methamphetamine (MA) use is growing to epidemic proportions and existing treatments for MA dependence demonstrate sub-optimal efficacy. Research implicates heavy use of MA as at least a contributing agent to a variety of neuropsychiatric impairments including psychosis, mood disturbance, anxiety, cognitive deficits, and motor dysfunction. Initial study by this investigator suggests that agents like risperidone may also be beneficial to MA dependent individuals by decreasing MA use and improving cognitive function in early abstinence. Long-acting injectable risperidone may prove more efficacious given its receptor binding characteristics and potential to increase medication adherence. The study objective is to determine the safety and efficacy of treating MA dependence and the associated cognitive and psychiatric symptomatology with long-acting injectable risperidone.
|Methamphetamine Dependence||Drug: long-acting injectable risperidone||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence|
- Efficacy will be assessed by obtaining weekly self-report measures of MA and other substance use via the timeline follow-back interview corroborated with weekly urine toxicology specimens for substances of abuse including amphetamines.
- Secondary efficacy measures include:
- changes in neuropsychological performance,
- changes in psychiatric symptomatology,
- by changes in addiction severity
|Study Start Date:||January 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284206
|United States, Washington|
|VA Puget Sound Health Care System, Addictions Treatment Center|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Andrew J Saxon||VA Puget Sound Health Care System, and University of Washington Dept. of Psychiatry and Behavioral Sciences|