Medication Adherence Therapy for Opioid Abusing Pain Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Medication compliance and unauthorized drug use
研究概览
简要总结
The purpose of this study is to develop and pilot test a combined behavioral and pharmacological intervention designed to decrease pain, functional interference, and drug abuse while increasing medication adherence.
详细描述
Project Pain is a Stage I behavioral therapies development project aimed at developing and pilot testing a novel intervention for patients with chronic non-malignant pain who have experienced difficulty managing prescribed opioids. The goals of the study are to: (1) develop the intervention and training materials; (2) develop therapist adherence and competence scales; (3) train therapists to deliver the intervention per the treatment protocol; and (4) pilot the intervention to assess its feasibility, acceptability and promise. The goals of the intervention are to: (1) improve adherence to prescribed opioids; (2) decrease the severity of patients' pain; and (3) improve patients' functioning and quality of life .
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
- None
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
- •Uninterrupted pain of at least 6 months duration
- •Pain is continuous, rather than intermittent
- •Pain in the severe range (VAS = 7-10) while medicated
- •Poor response to non-pharmacological interventions for pain (if appropriate)
- •One or more of the following pain diagnoses: (a) back/neck pain; (b) myofacial pain; (c) neuropathic pain (e.g., diabetic or AIDS neuropathy, Complex regional pain syndrome); (d) arthritic pain; (e) MS; or (f) sickle cell (must meet chronicity criteria)
- •Evidence of tolerance/physiological dependence on opioid analgesics
- •Current opioid use disorder (DSM-IV criteria)
- •Continuous use of opioid analgesics for a minimum of 6 months prior to referral. [Note: This is consistent with minimum 6-month requirement for diagnosis of chronic pain].
- •Minimum of 2 signs/symptoms of medication mismanagement identified by the Referring MD (PROBLEMS WITH PAIN MEDS checklist)
排除标准
- •Please contact site regarding exclusion criteria for this study.
研究组 & 干预措施
1
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
干预措施: Methadone (Drug)
2
Methadone plus behavioral counseling consisting of adherence
干预措施: Methadone (Drug)
结局指标
主要结局
Medication compliance and unauthorized drug use
时间窗: 24 weeks
Changes in pain severity and functioning
时间窗: 24 weeks
次要结局
- Satisfaction with services(12 weeks)
- Therapeutic alliance(12 weeks)