A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain
概览
- 阶段
- 不适用
- 干预措施
- Slow Tapering of Chronic Opioid Therapy
- 疾病 / 适应症
- Chronic Pain
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in measures of quality of life
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
The purpose of this study is to find out if patients who have been taking a stable dose of opioids for chronic pain would experience any worsening pain, quality of life and functioning, as well as symptoms of depression and anxiety if their opioid medications are gradually and very slowly reduced.
研究者
入排标准
入选标准
- •Ability to provide consent.
- •Ability to participate in all aspects of this study.
- •Using tablet or capsule form of one or two of the designated opioid preparations daily (at least 95% of days) during the previous 6 months, anticipated long term use and no active plans for tapering. Specific opioid preparations designated for inclusion will be based on the frequency of use by patients on the Chronic Opioid Registry as well as tablet or capsule characteristics which allow encapsulation by the Research Pharmacy. Participants who have been prescribed the following oral opioids will be recruited into the study: tramadol 50mg tablet or capsule; hydrocodone-acetaminophen (APAP) 5mg-325mg tablet or capsule; hydrocodone-APAP 7.5mg-325mg tablet or capsule; hydrocodone-APAP 10mg-325mg tablet or capsule; oxycodone 5mg tablet or capsule; oxycodone 10mg tablet or capsule; oxycodone-APAP 5mg-325mg tablet or capsule; oxycodone 10mg-325mg tablet or capsule; morphine sulfate extended release 15mg tablet or capsule; morphine sulfate extended release 30mg tablet or capsule; morphine sulfate immediate release 15mg tablet or capsule; morphine sulfate immediate release 30mg tablet or capsule.
- •Primary care provider prescribing chronic opioid therapy within MCHS NW WI and in agreement with patient participation.
- •Average daily morphine milligram equivalent (MME) dose at enrollment equal to or less than 90.
排除标准
- •Daily or intermittent use of transdermal, liquid, intravenous or intramuscular forms of opioid during the last 6 months.
- •Use of methadone or buprenorphine.
- •Use of an opioid containing preparation with three or more active ingredients.
- •Active cancer treatment, other than non-melanoma dermatological cancers. This includes patients either currently receiving or planning to receive any type of cancer treatment other than hormonal therapy.
- •Active or planned pregnancy.
- •COT being prescribed for indications other than chronic non-cancer pain (i.e., restless leg syndrome).
- •Enrollment in hospice care.
- •Active suicidal planning or intent as reported on PHQ
- •Acquisition of controlled medications from clinicians other than PCP or associated clinicians in the previous 6 months as noted in the Prescription Drug Monitoring Program.
- •Use of opioids and/or benzodiazepines other than those prescribed by PCP or associated clinicians, or the use of illicit substances other than THC, as found in urine drug testing within the previous 6 months.
研究组 & 干预措施
Slow Tapering of Chronic Opioid Therapy
Subjects who are on a stable dose of daily opioid therapy for at least 6 months will have their opioid medication doses slowly and gradually reduced every 4 weeks.
干预措施: Slow Tapering of Chronic Opioid Therapy
Continued Opioid Therapy
Subjects who are on a stable dose of daily opioid therapy for at least 6 months will stay on the same dose of opioids they are currently using at the beginning of the study for the entire 12-month duration of the study.
结局指标
主要结局
Changes in measures of quality of life
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months
Measured by the Medical Outcomes Study Questionnaire Short Form Health 36 Survey (SF36v2).The SF-36 is a multi-purpose self-reported survey designed to capture adult patients' perceptions of their own health and well-being.
次要结局
- Change in measures of depression(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in measures of anxiety(Baseline, 3 months, 6 months, 9 months, 12 months)