High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid After Failure of an Opioid Tapering-off Strategy.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Absence of opioid in urine test after rotation by HDB
研究概览
简要总结
The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics opioids use have increasingly been increased in chronic pain for 20 years. However, a long use, at least 3 months in this type of pain has not proved a large efficiency and we have noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In current practice, patients with chronic pain, often keep their analgesics opioids despite the absence of pain relief and benefits in quality of life.
Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with physical opioid dependence. The most common clinical strategy is progressive decrease of analgesic opioid. But this strategy is often a failure in these patients (no data are available in literature).
It's necessary to make a prospective pilot study to assess benefits from this practice.
The primary objective of this study is to assess a new ambulatory withdrawal strategy, consisting of a temporary opioid rotation with buprenorphine in CNCP patients suffering from physical withdrawal symptoms and who have failed a conventional strategy of progressive withdrawal from their opioid analgesic treatment.
详细描述
This study is designed as a type 2 multicenter clinical trial combining 3 Pain Clinics.
Patients were consecutively recruited from the active file of 3 Pain Clinics in France (Clermont-Ferrand, Vichy and le Puy-en-Velay). Patients meeting all inclusion criteria were enrolled after receiving oral and written information about the study and after obtaining written informed consent.
At baseline, they completed 5 questionnaires including: Brief Pain Inventory (BPI), Hospital Anxiety and Depression scale (HAD), Leeds sleep Evaluation Questionnaire (LSEQ), Short version of Short Form 36 Health Survey (SF 12), Clinical Opioid Withdrawal Scale (COWS) and underwent 2 tests with algometer and pupillometer. After inclusion, all patients started an opioid tapering-off protocol (Figure 1, Step 1) according to a standardized scheme of opioid gradual decrease defined by 3 medical experts in addictology, pain management and pharmacology.
Step 1 (from inclusion to 3 months): Patients will start to taper off their opioid dose according to a specific schedule. They will be seen by a physician on a monthly basis and contacted by phone 48-72h after each decrease in opioid dosage to detect withdrawal symptoms using the COWS specific scale. After 3 months, all patients who fail the opioid tapering-off protocol will be included in a non-responder group, while the others who succeed the withdrawal protocol will be included in a responder group:
- A responder will be defined by strict adherence to the schedule leading to a 50% reduction in the initial daily dose of opioid after 3 months. In this case, patients will continue with step 1 and decrease their opioid dose according to the same withdrawal protocol. They will be seen by a physician on a monthly basis and contacted by phone 48-72h after each stage of opioid dose reduction, until the opioid treatment is completely discontinued after 6 months of the withdrawal protocol. At 6 months, patients will fill out the same questionnaires and perform the same tests as at the baseline visit. Finally, after 9 months, patients will be contacted by phone to check that withdrawal is being maintained and to collect data on ongoing analgesic treatment.
- A non-responder will be defined as a failure of the withdrawal protocol, by non-compliance with the schedule, leading to a 50% reduction in the initial daily dose of opioid treatment after 3 months or when tapering off fails, leading the patient to re-increase the opioid dose. Thus, these patients will proceed to step 2 and start temporary rotation with buprenorphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 18 years,
- •patients with CNCP who have been treated for more than 6 months with a single opioid analgesic (weak or strong; long acting and/or immediate release),
- •Patients will be required to have an indication to stop or reduce opioid therapy (i.e. unfounded indication, tolerance, ineffectiveness, and/or adverse effects), and/or have physical withdrawal symptoms between opioid administrations (Clinical Opioid Withdrawal Scale (COWS) assessment),
- •Patients must have given their comprehensive informed consent and be affiliated with the French social security system.
排除标准
- •not have an opioid use disorder with craving (assessment by investigator according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) or misuse (assessment by the Prescription Opioid Misuse Index (POMI)[28]) related to opioid use,
- •ongoing treatment with ketamine,
- •chronic cancer pain,
- •contraindication to buprenorphine (hypersensitivity to an active substance or its excipients, severe hepatic and/or respiratory dysfunction, alcohol use disorder or delirium tremens),
- •alcohol use disorder,
- •pregnant or breastfeeding,
- •involved in any other interventional trial, or be subject to legal protection.
研究组 & 干预措施
Chronic pain patients
The primary objective of this study is to assess the success rate at 6 months of opioid temporary rotation by High Dosage Buprenorphine (HDB) taper dose in chronic non cancer pain patients (CNCP) with physical withdrawal symptoms making opioid withdrawal impossible.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Absence of opioid in urine test after rotation by HDB
时间窗: Month 6
Validating total opioid withdrawal (including HDB)
次要结局
- The pain will be assessed by the questionnaire Brief pain Inventory (BPI)(Day 1, Month 1, Month 6)
- Rate of opioid tapering-off protocol success by total taper opioid withdrawal(Month 6)
- The sleep will be assessed by questionnaire LSEQ (Leeds sleep evaluation questionnaire)(Day 1, Month 1, Month 6)
- Rate of opioid tapering-off protocol success by decrease of 50% of initial posology(Month 3)
- The anxiety and depression will be assessed by questionnaire HAD (Hospital anxiety and depression scale)(Day 1, Month 1, Month 6)
- The quality of life will be assessed by questionnaire SF12 (Short version of Short Form 36 Health Survey)(Day 1, Month 1, Month 6)
- Evaluation of pain intensity (NRS 0-10) by the pressure algometry measurement.(Day 1, Month 1, Month 6)
- Evaluation of the correlation between pupillary dilation (pupillometer) and pain (NRS 0-10).(Day 1, Month 1, Month 6)