Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Individuals will be recruited by posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization. Participants will be randomized into a Health Education study arm, and receive 7 individual sessions on general health education, or an Intervention study arm, and receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Pain, defined as pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale;
- •Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week";
- •Previous attempt at initial steps of PCP guideline pain care: must have had at least one trial of recommended medication (i.e. acetaminophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs;
- •QIDS score of ≥ 10 (depression severity)
- •If using an antidepressant, the dose must be stable for the previous 2 months;
- •Age 18 or older
- •Has received buprenorphine/naloxone (Suboxone)for at least the last 3 months;
- •Plan to continue buprenorphine/naloxone (Suboxone)for at least 3 months.
排除标准
- •Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition;
- •Current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, or cocaine;
- •Suicidal ideation or behavior requiring immediate attention;
- •In psychotherapy or in a multidisciplinary pain management program at baseline;
- •Anticipate having surgery in the next 6 months;
- •Pain thought to be due to cancer, infection, inflammatory arthritis, or associated with severe or progressive neurological deficits;
- •SSDI or SSI claim pending;
- •Pregnancy.
研究组 & 干预措施
TOPPS Intervention
Individuals randomized into this arm will receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention, designed to reduce symptoms of pain and depression.
干预措施: Treating Opioid Patients' Pain and Sadness (TOPPS) (Behavioral)
Health Education
Individuals randomized into this arm will receive 7 individual sessions on general health education.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Pain
时间窗: 4 months
Pain, as measured by self-report
次要结局
- Depression(4 months)
- Substance Use(4 months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital