NCT02882412

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 4, 2016

Last Update Submit

August 30, 2018

Conditions

Chronic Pain

Keywords

effectivenessbuprenorphine/naloxoneiatrogenic opioid dependence

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • psychiatric comorbidity

    baseline and change from baseline from DASS at 2 months

  • psychiatric comorbidity

    baseline and change from baseline from MINI at 2 months

  • craving

    baseline and change from baseline from OCDS at 2 months

  • degree of opioids dependence

    baseline and change from baseline from COMM at 2 months

  • psychiatric comorbidity

    baseline and change from baseline from PID-5-BF at 2 months

  • +4 more secondary outcomes

Study Arms (1)

patient group

Other: observational

Interventions

observationalOTHER
patient group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Arnt Schellekens, Phd, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffie van Rijswijk, MSc

CONTACT

steffie.vanrijswijk@radboudumc.nl

Arnt Schellekens

CONTACT

arnt.schellekens@radboudumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 29, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations

NL(1)