High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid

  • STATUS
    Not Recruiting
  • participants needed
    60
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 22 January 2021

Summary

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 the success rate at 6 months of opioid temporary rotation by High Dosage Buprenorphine (BHD) taper dose in chronic non cancer pain patients (CNCP) with physical withdrawal symptoms making opioid withdrawal impossible.

Description

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 start to taper off their analgesic opioid dosage according to a specific schedule. They will be seen by a doctor every month and will be contacted by phone 48-72h after every stage of opioid dosage decrease to detect withdrawal symptoms using the specific COWS scale.

The responder status is defined by the strict adherence to the schedule leading to a 50% decrease at 3 months of the initial daily dosage of the analgesic opioid. In this case, patients will continue Step 1 and will keep on tapering off their analgesic opioid according to the same protocol and will be seen by a doctor every month and will be contacted by phone 48-72h after every stage of opioid dosage decrease until total withdrawal at 6 months. At 6 months, they will undergo the same questionnaires and tests performed at baseline (BPI, HAD, LSEQ, SF 12, COWS and algometer, pupillometer). At 9 months, patients will be contacted by phone to check for the maintenance of withdrawal and to collect analgesic treatment.

The non-responder status is defined by a failure in the scheduled dosage decrease consisting in the need for the patient to re-increase the opioid dosage after a stage of decrease. These patients will enter the step 2 and start the temporary rotation by HDB (Step2).

Step 2: HDB is started (J0) at the dosage of 4 mg/ day (with a possible adjustment 2 mg at 24h, depending on the patient withdrawal symptoms intensity or tolerance). Two visits at J0+7 days and J0+14 days are planned to assess the efficacy and safety of HDB. The treatment will be continued for a 1-month period at the same dosage. At J0+1 month, a tapering-off period of 5 months will start until total withdrawal of HDB is achieved at J0+6 months (decrease of 1 mg per month). Patients will be seen by a doctor every month and will be contacted by phone 48-72h after every stage of HDB dosage decrease until total withdrawal at J0+6 months. Questionnaires (BPI, HAD, LSEQ, SF 12, COWS) and tests (algometer and pupillometer) will be repeated at J0, J0+1 month and J0+6 months. A urinary test will be performed at J0, J0+1 month and J0+6 months to evaluate primary outcome. At 9 months, patients will be contacted by phone to check for the maintenance of withdrawal and to collect analgesic treatment.

Details
Condition High Dosage Buprenorphine
Treatment Buprenorphine/naloxone
Clinical Study IdentifierNCT03156907
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on22 January 2021

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