A Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborator: Janssen, LP
• Treatments: Methamphetamine; Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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