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

• Status: Active, not recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Analgesics; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.