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Trial record 38 of 186 for:    BUPRENORPHINE AND NALOXONE

Effectiveness of Buprenorphine/Naloxone

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ClinicalTrials.gov Identifier: NCT02882412
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment
Chronic Pain 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Buprenorphine/Naloxone in Patients With Chronic Pain and Iatrogenic Opioid Dependence
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
patient group Other: observational



Primary Outcome Measures :
  1. 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

  2. withdrawal symptoms [ Time Frame: baseline and change from baseline from OWS at 2 months ]
    OWS: Objective Withdrawal Scale

  3. 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

  4. withdrawal symptoms [ Time Frame: baseline and change from baseline from SWS at 2 months ]
    SWS: Subjective Withdrawal Scale


Secondary Outcome Measures :
  1. psychiatric comorbidity [ Time Frame: baseline and change from baseline from DASS at 2 months ]
    DASS: Depression Anxiety Stress Scale

  2. psychiatric comorbidity [ Time Frame: baseline and change from baseline from MINI at 2 months ]
    MINI: Mini International neuropsychiatric Interview

  3. craving [ Time Frame: baseline and change from baseline from OCDS at 2 months ]
    OCDS: Obsessive Compulsive Drug using Scale

  4. degree of opioids dependence [ Time Frame: baseline and change from baseline from COMM at 2 months ]
    COMM: Current Opioid Misuse Measure

  5. psychiatric comorbidity [ Time Frame: baseline and change from baseline from PID-5-BF at 2 months ]
    PID-5-BF: Personality Inventory for DSM-5

  6. psychiatric comorbidity [ Time Frame: baseline and change from baseline from TAS-20 at 2 months ]
    TAS-20: the 20-item Toronto Alexithymia Scale

  7. psychiatric comorbidity [ Time Frame: baseline and change from baseline from IDS at 2 months ]
    IDS: Inventory of Depressive Symptomatology

  8. psychiatric comorbidity [ Time Frame: baseline and change from baseline from PTQ at 2 months ]
    PTQ: The Perseverative Thinking Questionnaire

  9. 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 ]
    EQ5D: EuroQol five dimensions questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882412


Contacts
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Contact: Steffie van Rijswijk, MSc steffie.vanrijswijk@radboudumc.nl
Contact: Arnt Schellekens arnt.schellekens@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Steffie van Rijswijk, MSc       steffie.vanrijswijk@radboudumc.nl   
Contact: Arnt Schellekens, Phd, MD       arnt.schellekens@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Arnt Schellekens, Phd, MD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02882412     History of Changes
Other Study ID Numbers: 2015-1551
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Radboud University:
effectiveness
buprenorphine/naloxone
iatrogenic opioid dependence
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists