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

NCT03156907 | Unknown Phase 2

• 2 other identifiers: CHU-3252015-003173-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Dosage Buprenorphine

Keywords

High dosage Buprenorphine (HDB); Chronic pain; Analgesics opioids; Withdrawal symptoms

Outcome Measures

Primary Outcomes (1)

• Absence of opioid in urine test after rotation by HDB

  Validating total opioid withdrawal (including HDB)

  Month 6

Secondary Outcomes (8)

• Rate of opioid tapering-off protocol success by decrease of 50% of initial posology

  Month 3

• Rate of opioid tapering-off protocol success by total taper opioid withdrawal

  Month 6

• The pain will be assessed by the questionnaire Brief pain Inventory (BPI)

  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

• The anxiety and depression will be assessed by questionnaire HAD (Hospital anxiety and depression scale)

  Day 1, Month 1, Month 6

Study Arms (1)

Chronic pain patients

EXPERIMENTAL

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.

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

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).

Chronic pain patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (1)

• Bertin C, Kerckhove N, Ferrer F, Pereira B, Duale C, Richard D, Authier N, Delage N. Buprenorphine Substitution as a Tapering Strategy for Opioid Discontinuation in Patients with Chronic Pain: A Nonrandomized and Proof of Concept Study. Pain Ther. 2025 Dec;14(6):1783-1795. doi: 10.1007/s40122-025-00781-z. Epub 2025 Oct 3.

  PMID: 41042438 DERIVED

MeSH Terms

Conditions

Chronic Pain; Substance Withdrawal Syndrome

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 17, 2017
• Study Start: September 15, 2017
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 6, 2021

Record last verified: 2021-06

Locations

FR (1)