Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adherence rate
研究概览
简要总结
The purpose of the study is to investigate new therapies to alleviate pain on neuropathic chronic pain. At this time, the main purpose is to complete a feasibility or pilot study with 60 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosis of chronic neuropathic pain as determined by a pain specialist with moderate-to-severe neuropathic pain as per ID pain questionnaire, with mean pain scores > 3 on a numeric rating scale (NRS), in the 7 days preceding inclusion
- •For participants of childbearing potential, use highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant
- •Capacity to provide informed consent
排除标准
- •Patients less than 18 years of age
- •Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder
- •Known history of hypersensitivity or allergy to Ketamine-HCL
- •Current history of dissociative disorders
- •Current concomitant use of theophylline or aminophylline
- •Current elevated intracranial pressure
- •Pregnancy or ongoing breastfeeding in female participants
- •Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
- •Contraindication to receiving Ketamine-HCL (e.g. current or lifetime history of cerebrovascular accident; current significant hypertension [systolic blood pressure higher than 160 mmHg and/or diastolic blood pressure higher than 100 mmHg]; current severe cardiac decompensation [e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions])
研究组 & 干预措施
Ketamine only
干预措施: Ketamine Hydrochloride (Drug)
Psychotherapy only
干预措施: Cognitive Behavioral Therapy (Behavioral)
Ketamine + Psychotherapy
干预措施: Ketamine + Cognitive Behavioral Therapy (Other)
结局指标
主要结局
Adherence rate
时间窗: 2 years
Feasibility
Frequency of adverse events
时间窗: 2 years
Safety and tolerability
Recruitment rate
时间窗: 2 years
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
次要结局
- Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.(20 weeks)
- Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,(20 weeks)