Chronic PainNCT02882412
Effectiveness of Buprenorphine/Naloxone
An observational study of Chronic Pain, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- observational
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Steffie van Rijswijk, MSc contact
Arnt Schellekens contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Steffie van Rijswijk, MSc, steffie.vanrijswijk@radboudumc.nl
Arnt Schellekens, Phd, MD, arnt.schellekens@radboudumc.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- observational
- Keywords
- effectiveness, buprenorphine/naloxone, iatrogenic opioid dependence
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
| Study group | Role | What they receive |
|---|---|---|
| patient group | Not described Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with QST baseline and change from baseline from QST at 2 months
QST: Quantitative Sensory Testing
Measured: baseline and change from baseline from QST at 2 months
withdrawal symptoms
OWS: Objective Withdrawal Scale
Measured: 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
Measured: baseline and change from baseline from VAS at 2 months
withdrawal symptoms
SWS: Subjective Withdrawal Scale
Measured: baseline and change from baseline from SWS at 2 months
Secondary outcomes (9)
psychiatric comorbidity
DASS: Depression Anxiety Stress Scale
Measured: baseline and change from baseline from DASS at 2 months
psychiatric comorbidity
MINI: Mini International neuropsychiatric Interview
Measured: baseline and change from baseline from MINI at 2 months
craving
OCDS: Obsessive Compulsive Drug using Scale
Measured: baseline and change from baseline from OCDS at 2 months
degree of opioids dependence
COMM: Current Opioid Misuse Measure
Measured: baseline and change from baseline from COMM at 2 months
psychiatric comorbidity
PID-5-BF: Personality Inventory for DSM-5
Measured: baseline and change from baseline from PID-5-BF at 2 months
psychiatric comorbidity
TAS-20: the 20-item Toronto Alexithymia Scale
Measured: baseline and change from baseline from TAS-20 at 2 months
psychiatric comorbidity
IDS: Inventory of Depressive Symptomatology
Measured: baseline and change from baseline from IDS at 2 months
psychiatric comorbidity
PTQ: The Perseverative Thinking Questionnaire
Measured: 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
Measured: baseline and change from baseline from EQ5D at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnt Schellekens, Phd, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882412
- Sponsor's protocol ID
- 2015-1551
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Buprenorphine/Naloxone in Patients With Chronic Pain and Iatrogenic Opioid Dependence
- ClinicalTrials.gov ID
- NCT02882412
- Acronym / sponsor ID
- 2015-1551
- Conditions
- Chronic Pain
- Keywords
- effectiveness, buprenorphine/naloxone, iatrogenic opioid dependence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Other: observational |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational | Other | patient group |
Primary outcome
Pain with QST baseline and change from baseline from QST at 2 months
Time frame: baseline and change from baseline from QST at 2 months
QST: Quantitative Sensory Testing
withdrawal symptoms
Time frame: baseline and change from baseline from OWS at 2 months
OWS: Objective Withdrawal Scale
Pain with VAS baseline and change from baseline from QST at 2 months
Time frame: baseline and change from baseline from VAS at 2 months
VAS: Visual Analogue Scale
withdrawal symptoms
Time frame: baseline and change from baseline from SWS at 2 months
SWS: Subjective Withdrawal Scale
9 secondary outcomes
psychiatric comorbidity
Time frame: baseline and change from baseline from DASS at 2 months
psychiatric comorbidity
Time frame: baseline and change from baseline from MINI at 2 months
craving
Time frame: baseline and change from baseline from OCDS at 2 months
degree of opioids dependence
Time frame: baseline and change from baseline from COMM at 2 months
psychiatric comorbidity
Time frame: baseline and change from baseline from PID-5-BF at 2 months
psychiatric comorbidity
Time frame: baseline and change from baseline from TAS-20 at 2 months
psychiatric comorbidity
Time frame: baseline and change from baseline from IDS at 2 months
psychiatric comorbidity
Time frame: 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
Time frame: baseline and change from baseline from EQ5D at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffie van Rijswijk, MSc contact
Arnt Schellekens contact
Arnt Schellekens, Phd, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffie van Rijswijk, MSc (steffie.vanrijswijk@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with QST baseline and change from baseline from QST at 2 months (time frame: baseline and change from baseline from QST at 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.