Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284206
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2006-01-27
Brief Title:
A Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
An Open-Label Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
-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
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 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
Research Plan
-This is an open-label trial of long-acting injectable risperidone administered 25mg every 2-weeks for the treatment of methamphetamine MA dependence Participation will last approximately 14 weeks A total of 20 subjects veterans and non-veterans aged 18 to 65 years old who meet DSM-IV criteria for current MA dependence have a stable address or alternative contact and expect to be in the Puget Sound area for the length of the study will be enrolled at the Seattle and American Lake Divisions of the VA PSHCS Exclusionary criteria include 1 known sensitivity or allergy to risperidone 2 current treatment with an antipsychotic agent a mood stabilizer or CYP 2D6 inhibitor 3 transaminase levels 5X ULN 4 albumin levels 35gdl 5 random serum glucose levels 200mgdl 6 diabetes mellitus or history of myocardial infarction 7 baseline Brief Psychiatric Rating Scale score 72 8 presence of tardive dyskinesia 9 Barnes Akathisia Rating Scale global item score 2 10 Simpson-Angus Scale total score 03 11 involvement with the legal system that could compromise study participation 12 pregnancy or nursing 13 receiving current mental health treatment
Methodology
-Potential subjects will complete a screening including medical history and physical laboratory EKG assessment of MA and other drug use psychiatric screening and cognitive testing to determine eligibility Eligible subjects will repeat the cognitive testing instruments prior to starting medication After completing the screening period subjects who continue to be eligible will receive 7 days of oral risperidone to assess tolerability followed by administration of long-acting injectable risperidone 25mg For 3 weeks following the first IM injection participants will take oral risperidone each night to achieve a therapeutic plasma level of risperidone During the oral co-administration phase participants will have medication pill counts during their weekly visit to evaluate adherence and corroborate self-report data Participants will receive additional 25mg risperidone injections every 14 days at weeks 2 4 and 6 after the first injection
Following the first injection subjects will return to the study center for weekly visits for 8 weeks At each study visit patients will be evaluated for possible adverse events use of concomitant medications and use of methamphetamine Safety labs will be repeated at week 4 and 8 Plasma levels of risperidone and 9-OH-risperidone will be obtained at 3 6 and 8 weeks If intolerable adverse events occur risperidone dosage will be reduced or if indicated risperidone will be discontinued Psychiatric symptoms and cognitive functioning will be evaluated at Baseline and 4 and 8 weeks A follow-up visit will take place at 12 weeks Subjects will receive behavioral treatment consisting of individual once weekly standardized manual guided relapse prevention therapy
Findings results or conclusions reached to date
-None to date
-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
Research Plan
-This is an open-label trial of long-acting injectable risperidone administered 25mg every 2-weeks for the treatment of methamphetamine MA dependence Participation will last approximately 14 weeks A total of 20 subjects veterans and non-veterans aged 18 to 65 years old who meet DSM-IV criteria for current MA dependence have a stable address or alternative contact and expect to be in the Puget Sound area for the length of the study will be enrolled at the Seattle and American Lake Divisions of the VA PSHCS Exclusionary criteria include 1 known sensitivity or allergy to risperidone 2 current treatment with an antipsychotic agent a mood stabilizer or CYP 2D6 inhibitor 3 transaminase levels 5X ULN 4 albumin levels 35gdl 5 random serum glucose levels 200mgdl 6 diabetes mellitus or history of myocardial infarction 7 baseline Brief Psychiatric Rating Scale score 72 8 presence of tardive dyskinesia 9 Barnes Akathisia Rating Scale global item score 2 10 Simpson-Angus Scale total score 03 11 involvement with the legal system that could compromise study participation 12 pregnancy or nursing 13 receiving current mental health treatment
Methodology
-Potential subjects will complete a screening including medical history and physical laboratory EKG assessment of MA and other drug use psychiatric screening and cognitive testing to determine eligibility Eligible subjects will repeat the cognitive testing instruments prior to starting medication After completing the screening period subjects who continue to be eligible will receive 7 days of oral risperidone to assess tolerability followed by administration of long-acting injectable risperidone 25mg For 3 weeks following the first IM injection participants will take oral risperidone each night to achieve a therapeutic plasma level of risperidone During the oral co-administration phase participants will have medication pill counts during their weekly visit to evaluate adherence and corroborate self-report data Participants will receive additional 25mg risperidone injections every 14 days at weeks 2 4 and 6 after the first injection
Following the first injection subjects will return to the study center for weekly visits for 8 weeks At each study visit patients will be evaluated for possible adverse events use of concomitant medications and use of methamphetamine Safety labs will be repeated at week 4 and 8 Plasma levels of risperidone and 9-OH-risperidone will be obtained at 3 6 and 8 weeks If intolerable adverse events occur risperidone dosage will be reduced or if indicated risperidone will be discontinued Psychiatric symptoms and cognitive functioning will be evaluated at Baseline and 4 and 8 weeks A follow-up visit will take place at 12 weeks Subjects will receive behavioral treatment consisting of individual once weekly standardized manual guided relapse prevention therapy
Findings results or conclusions reached to date
-None to date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None