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

NCT00284206 | Completed Phase 2

• 1 other identifier: RIS-NAP-4008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine, cognition, outpatient, risperidone

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• Secondary efficacy measures include:

• changes in neuropsychological performance,

• changes in psychiatric symptomatology,

• by changes in addiction severity

Interventions

long-acting injectable risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Janssen, LP: collaborator

Study Sites (1)

VA Puget Sound Health Care System, Addictions Treatment Center

Seattle, Washington, 98108, United States

Location

Study Officials

• Andrew J Saxon

  VA Puget Sound Health Care System, and University of Washington Dept. of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 31, 2006
• Study Start: January 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

US (1)