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Effectiveness of Buprenorphine/Naloxone

Unknown statusNCT02882412
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
Effectiveness of Buprenorphine/Naloxone in Patients With Chronic Pain and Iatrogenic Opioid Dependence
Conditions
Sponsor
Radboud University Medical Center
Start date
2016-03
Primary completion
2019-03
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02882412