A Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT00284206|
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : January 11, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Drug: long-acting injectable risperidone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|