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

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00284206
First received: January 27, 2006
Last updated: January 3, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Methamphetamine Dependence
 Drug: long-acting injectable risperidone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • 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:
  • Secondary efficacy measures include:
  • changes in neuropsychological performance,
  • changes in psychiatric symptomatology,
  • by changes in addiction severity

Estimated Enrollment: 20
Study Start Date: January 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284206

Locations
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
Investigators
Principal Investigator: Andrew J Saxon VA Puget Sound Health Care System, and University of Washington Dept. of Psychiatry and Behavioral Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284206     History of Changes
Other Study ID Numbers: RIS-NAP-4008
Study First Received: January 27, 2006
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
methamphetamine, cognition, outpatient, risperidone

Additional relevant MeSH terms:
Methamphetamine
Amphetamine
Risperidone
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
 Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on May 23, 2013