Opioid use disorder
Conditions
Interventions
Trade Name: Suboxone
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 or over. - Meet ICD-11 criteria for chronic non-cancer pain. - Using a prescribed opioid with a morphine equivalent dose of over 60 mg per day for =3 months. - Have an opioid use disorder according to the DSM-5. - Wish to be treated for opioid use disorder. - Willing to comply to study procedures. - Be able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Pregnant, lactating, or planning to become pregnant during the study period. - Have already used buprenorphine or methadone in the last 4 weeks as a maintenance therapy. - Escalated use of another substance that prevents safe participation in the study. - Have acute psychiatric comorbidity. - Severe respiratory insufficiency or depression, such as severe chronic obstructive pulmonary disease GOLD 3 or 4. - Serious medical disease, such as severe liver dysfunction (Child-Pugh B or C), severe renal dysfunction (eGFR (MDRD) =29), heart failure, current brain trauma). - A Q-T interval of =450 ms on an electrocardiograph (ECG). - Hypersensitivity or allergy for buprenorphine, naloxone, methadone or any other substance in the preparations of these medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectivity of suboxone and methadone on reducing self-reported opioid misuse. ;Secondary Objective: - To compare the effectivity of suboxone and methadone on reducing pain. - To compare the effects of suboxone and methadone on well-being. - To compare the effects of suboxone and methadone on drug use. ;Primary end point(s): The mean score on the Current Opioid Misuse Measure (COMM) questionnaire compared from baseline to two months after initiation of treatment between the suboxone and methadone treatment groups.;Timepoint(s) of evaluation of this end point: 2 months after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The mean scores on the following measures, compared between both treatments from baseline to two and six months after initiation of treatment. Questionnaires: COMM, VAS-pain, BPI, CSI, VAS-QOL, WHOQOLBREF, DASS, VAS-craving, OCDS, GPE, ORSDS, FFMQ-SF, SCS, TCQ, CFQ. Tests: quantitative sensory testing, 6-minutes walking test, urine toxicology, MoCA, 15WT, SCWT, PASAT. Other: dose of drug, treatment retention. We will also ask patients to fill the SOAPP-R, SR-MAD and ORT questionnaires, to validate these questionnaires. A genetic sample will be taken to study whether genetic data can predict treatment outcomes. ;Timepoint(s) of evaluation of this end point: 2 and 6 months after initiation of treatment. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of psychiatry
Radboud University Medical Center
Outcome results
None listed