NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Treatment Response
研究概览
简要总结
This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD.
The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).
详细描述
Effective management for methamphetamine use disorder (MUD) remains elusive, despite widespread misuse of this stimulant. Psychological interventions have demonstrated modest benefits, and relapse rates are high. There are currently no Food and Drug Administration (FDA)-approved pharmacotherapies for MUD. This study explores the efficacy, safety, and feasibility for intravenous (IV) ketamine as a treatment for MUD and will help to determine the effect size for a larger, multi-site trial of intravenous (IV) ketamine in MUD.
Participants will receive either IV ketamine (0.50mg/kg) or IV midazolam (0.02mg/kg) over 45 minutes per infusion for a total of eight (8) infusions over six (6) weeks. Medical management sessions with a study clinician will be provided to all participants once weekly (from Weeks 1 through 6).
The use of IV ketamine in this trial is consistent in dose (0.5 mg/kg) and duration of infusion (45-minute-long) to other studies of ketamine for psychiatric disorders (such as major depressive disorder and post-traumatic stress disorder, both of which are often comorbid in individuals with MUD) and substance use disorder. However, IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet.
Additionally, participants will be asked to participate in cognitive behavioral therapy (CBT) sessions once weekly (from Weeks 1 through 12) on a non-infusion day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Study participants must:
- •Be 18 to 65 years old
- •Be able to sufficiently understand, speak, and read English
- •Be interested in reducing or stopping methamphetamine use
- •Meet criteria for methamphetamine use disorder
- •Use acceptable methods of contraception during participation in the study
排除标准
- •Study participants must not:
- •Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
- •Be currently in jail, prison, or inpatient overnight facility as required by court of law
- •Have upcoming surgery planned or scheduled
- •Be currently pregnant, breastfeeding, or planning on conception, if biologically female
- •Additional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.
研究组 & 干预措施
Ketamine
Participants will receive IV ketamine (0.50mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump at a constant rate over 40 minutes. IV ketamine will be administered 8 times over 6 weeks.
干预措施: Ketamine Hydrochloride (Drug)
Midazolam
Participants will receive IV midazolam (0.02mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump at a constant rate over 40 minutes. IV midazolam will be administered 8 times over 6 weeks.
干预措施: Midazolam Hydrochloride (Drug)
结局指标
主要结局
Treatment Response
时间窗: 2 weeks
Defined as having at least three methamphetamine-negative urine samples out of four samples obtained during Weeks 3 and 4.
次要结局
- Adherence to treatment(6 weeks)
- Total abstinence(2 weeks)
- Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use(6 weeks)
- Abstinence from methamphetamine use(12 weeks)
- Differences in methamphetamine-negative urine samples from Weeks 1 to 6 and between ketamine and midazolam arms.(6 weeks)
- Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4.(4 weeks)
研究者
Madhukar H. Trivedi, MD
Professor-Psychiatry
University of Texas Southwestern Medical Center