Status:
COMPLETED
A Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
Janssen, LP
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for methamphetamine (MA) dependence during the past year with current MA use within the 30-days prior to study entry
- Plans to remain in the Puget Sound area for the following 12 weeks
- If female of child bearing potential, agreeable to using an adequate method of birth control
- Age 18-65 years old
- Willing and capable of providing informed consent
- Presence of one or more of the following: stable address, telephone number, or alternative contact person
Exclusion
- Known sensitivity or allergy to risperidone
- Current treatment with an antipsychotic agent
- Current treatment with a mood stabilizer
- Current treatment with a CYP 2D6 inhibitor (includes Amiodarone, Bupropion, Celecoxib, Cimetidine, Chlorpromazine, Clomipramine, Fluoxetine, Haloperidol, Methadone, Moclobemide, Paroxetine, Quinidine, Ritonavir, Sertraline, Terbinafine and Thioridazine)
- Presence of tardive dyskinesia
- A global item score \>2 on the Barnes Akathisia Rating Scale.
- A total score on the Simpson-Angus Scale \> 0.3.
- Albumin level \<3.5g/dl.
- Random serum glucose level \>200mg/dl.
- Transaminase levels \> 5X ULN
- Presence of one or more of the following medical conditions: diabetes mellitus or history of myocardial infarction.
- A total score on the Brief Psychiatric Rating Scale \>72.
- Involvement with the legal system that could compromise study participation
- Pregnancy or nursing
- Receiving concurrent mental health treatment in addition to the study
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00284206
Start Date
January 1 2006
End Date
August 1 2007
Last Update
January 11 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Puget Sound Health Care System, Addictions Treatment Center
Seattle, Washington, United States, 98108