Chronic Pain Clinical Trial
Official title:
Effectiveness of Buprenorphine/Naloxone in Patients With Chronic Pain and Iatrogenic Opioid Dependence
NCT number | NCT02882412 |
Other study ID # | 2015-1551 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | March 2019 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | withdrawal symptoms | OWS: Objective Withdrawal Scale | baseline and change from baseline from OWS at 2 months | |
Primary | 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 | |
Primary | withdrawal symptoms | SWS: Subjective Withdrawal Scale | baseline and change from baseline from SWS at 2 months | |
Secondary | psychiatric comorbidity | DASS: Depression Anxiety Stress Scale | baseline and change from baseline from DASS at 2 months | |
Secondary | psychiatric comorbidity | MINI: Mini International neuropsychiatric Interview | baseline and change from baseline from MINI at 2 months | |
Secondary | craving | OCDS: Obsessive Compulsive Drug using Scale | baseline and change from baseline from OCDS at 2 months | |
Secondary | degree of opioids dependence | COMM: Current Opioid Misuse Measure | baseline and change from baseline from COMM at 2 months | |
Secondary | psychiatric comorbidity | PID-5-BF: Personality Inventory for DSM-5 | baseline and change from baseline from PID-5-BF at 2 months | |
Secondary | psychiatric comorbidity | TAS-20: the 20-item Toronto Alexithymia Scale | baseline and change from baseline from TAS-20 at 2 months | |
Secondary | psychiatric comorbidity | IDS: Inventory of Depressive Symptomatology | baseline and change from baseline from IDS at 2 months | |
Secondary | psychiatric comorbidity | PTQ: The Perseverative Thinking Questionnaire | baseline and change from baseline from PTQ at 2 months | |
Secondary | 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 |
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