An Open-Label Trial of Long-Acting Injectable Risperidone in the Treatment of Methamphetamine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 <3.5g/dl; (5) random serum glucose levels >200mg/dl; (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 > 0.3; (11) involvement with the legal system that could compromise study participation; (12) pregnancy or nursing; (13) receiving current mental health treatment.
Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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 >
- •Involvement with the legal system that could compromise study participation
- •Pregnancy or nursing
- •Receiving concurrent mental health treatment in addition to the study
结局指标
主要结局
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.
次要结局
- Secondary efficacy measures include:
- changes in neuropsychological performance,
- changes in psychiatric symptomatology,
- by changes in addiction severity