Effectiveness of Buprenorphine/Naloxone

Effectiveness of Buprenorphine/Naloxone in Patients With Chronic Pain and Iatrogenic Opioid Dependence

Long-term use of opioids for chronic pain is a growing health and social problem, mainly because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy for opioid dependence. This substitution therapy in patients with opioid dependence lessens withdrawal symptoms and craving. There is limited research on the effectiveness of buprenorphine/naloxone in patients with chronic pain and iatrogenic opioid dependence. The primary aim of this study is to investigate the effectiveness of buprenorphine/naloxone in patients suffering from chronic pain and an iatrogenic induced dependence on opioids. This study will investigate the effects of opioid substitution by buprenorphine/naloxone in patients suffering from chronic pain using long-term opioids, with pain and withdrawal symptoms as primary outcome measures. Secondary outcome measures will be craving, substance use, psychiatric comorbidity and quality of life.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Other: observational

Detailed Description

This is a prospective open-label observational cohort study (exploratory pilot). Investigators will include 20 patients between 18 and 65 years with chronic pain and dependence on opioids, who were referred by their physician for replacement of opioids to buprenorphine/naloxone. Exclusion criteria are contraindications for buprenorphine/naloxone and patients with psychiatric disorders requiring acute treatment. The degree of pain and withdrawal symptoms will be assessed by the Quantitative Sensory Testing (QST) measurement and the following questionnaires: Visual Analog Scale (VAS), Objective Withdrawal Scale (OWS) and Subjective Withdrawal Scale (SWS). Secondary, craving and substance use/degree of opioid dependence will be studied using the Current Opioid Misuse Measure (COMM) and Obsessive Compulsive Drug using Scale (OCDS). Psychiatric comorbidity will be assessed using the following questionnaires: Depression, Anxiety and Stress Scale (DASS), Personality Inventory for DSM-5 (PID 5-BF), The 20-item Toronto Alexithymia Scale (TAS-20), Inventory of Depressive Symptomatology (IDS), the Perseverative Thinking Questionnaire (PTQ) and Mini International Neuropsychiatric Interview (MINI). These questionnaires are part of the standard assessment at the department of psychiatry at the Radboud University Medical Centre, Nijmegen. The EuroQol five dimensions questionnaire (EQ5D) will be used to assess the quality of life. During the replacement of opioids to buprenorphine/naloxone, the buprenorphine/naloxone protocol will be used.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Recruiting
    • Radboudumc
    • Contact: Steffie van Rijswijk, MSc; Email: steffie.vanrijswijk@radboudumc.nl
    • Contact: Arnt Schellekens, Phd, MD; Email: arnt.schellekens@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult men and women aged 18 to 65 years suffering from chronic pain (pain for more than 6 months) and iatrogenic opioid dependence (according to the DSM-5 criteria).

Description

Inclusion Criteria:

• Adult men and women aged 18 to 65 years
• suffering from chronic pain (pain for more than 6 months)
• iatrogenic opioid dependence (according to the DSM-5 criteria)
• there is informed consent for using the data for scientific analyses.

Exclusion Criteria:

• Contraindications for buprenorphine/naloxone, such as severe respiratory insufficiency, severe hepatic insufficiency, alcohol intoxication or delirium tremens.
• In addition participants with psychiatric disorders requiring acute treatment will be excluded, for instance an acute psychosis, acute manic episode or patients who are suicidal.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient group	Other: observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with QST baseline and change from baseline from QST at 2 months	QST: Quantitative Sensory Testing	baseline and change from baseline from QST at 2 months
withdrawal symptoms	OWS: Objective Withdrawal Scale	baseline and change from baseline from OWS at 2 months
Pain with VAS baseline and change from baseline from QST at 2 months	VAS: Visual Analogue Scale	baseline and change from baseline from VAS at 2 months
withdrawal symptoms	SWS: Subjective Withdrawal Scale	baseline and change from baseline from SWS at 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychiatric comorbidity	DASS: Depression Anxiety Stress Scale	baseline and change from baseline from DASS at 2 months
psychiatric comorbidity	MINI: Mini International neuropsychiatric Interview	baseline and change from baseline from MINI at 2 months
craving	OCDS: Obsessive Compulsive Drug using Scale	baseline and change from baseline from OCDS at 2 months
degree of opioids dependence	COMM: Current Opioid Misuse Measure	baseline and change from baseline from COMM at 2 months
psychiatric comorbidity	PID-5-BF: Personality Inventory for DSM-5	baseline and change from baseline from PID-5-BF at 2 months
psychiatric comorbidity	TAS-20: the 20-item Toronto Alexithymia Scale	baseline and change from baseline from TAS-20 at 2 months
psychiatric comorbidity	IDS: Inventory of Depressive Symptomatology	baseline and change from baseline from IDS at 2 months
psychiatric comorbidity	PTQ: The Perseverative Thinking Questionnaire	baseline and change from baseline from PTQ at 2 months
Quality of life with EQ5D baseline and change from baseline from EQ5D at 2 months	EQ5D: EuroQol five dimensions questionnaire	baseline and change from baseline from EQ5D at 2 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Arnt Schellekens, Phd, MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: effectiveness; buprenorphine/naloxone; iatrogenic opioid dependence
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2015-1551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED