drugset / Trial / NCT03156907

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

NCT03156907

Phase 2 Unknown 60 enrolled University Hospital, Clermont-Ferrand
NaSingle-groupOpen-labelTreatment

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 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.

Timeline

Start
2017-09-15
Primary completion
2024-12
Completion
2025-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 4 mg

Indications

No indication recorded.