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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284206
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : January 11, 2008
Janssen, LP
Information provided by:
Seattle Institute for Biomedical and Clinical Research

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Secondary efficacy measures include:
  2. changes in neuropsychological performance,
  3. changes in psychiatric symptomatology,
  4. by changes in addiction severity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00284206

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United States, Washington
VA Puget Sound Health Care System, Addictions Treatment Center
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
Janssen, LP
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Principal Investigator: Andrew J Saxon VA Puget Sound Health Care System, and University of Washington Dept. of Psychiatry and Behavioral Sciences
Layout table for additonal information Identifier: NCT00284206    
Other Study ID Numbers: RIS-NAP-4008
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
methamphetamine, cognition, outpatient, risperidone
Additional relevant MeSH terms:
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Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents