The primary objective is to compare the effectivity of buprenorphine/naloxone and methadone onself-reported opioid misuse. Secondary objectives include comparing the effects on pain, well-being, functioning, and medication use.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Health condition
(Iatrogenic) opioid use disorder, chronic non-malignant pain.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect of suboxone and methadone on self-reported opioid misuse.
Secondary outcome
Effects of suboxone and methadone on; - pain (pain intensity, central sensitization , functional interference due to pain); - well-being (quality of life, depression, anxiety, stress, opioid craving, physical functioning, cognitive functioning, perceived recovery); - drug/medication use (dose of original and substitution opioids, concomitant drug and medication use); - side effects; - treatment retention.
Background summary
Opioid substitution therapy (OST) is a common and effective form of pharmacotherapy in
patients with an opioid use disorder and can be done with either buprenorphine or
methadone. While these medications have been compared in patients with dependency on
illicit opioids, research in patients with dependency on prescription opioids is scarce. It is
currently unclear whether buprenorphine or methadon is most effective option in this
population. In an open-label, randomized, two-arm, clinical trial, current opioid medication
will be substituted by either of these medications.
Study objective
The primary objective is to compare the effectivity of buprenorphine/naloxone and methadone on
self-reported opioid misuse. Secondary objectives include comparing the effects on pain, well-being, functioning, and medication use.
Study design
Open-label randomized controlled trial comparing rotation to methadone with buprenorphine/naloxone in patients with chronic pain and opioid use disorder. Follow-up is six months.
Intervention
Suboxone (buprenorphine/naloxone) vs. methadone.
Study burden and risks
Opioid substitution therapies with suboxone or methadone significantly increase treatment outcomes compared to treatment without pharmacotherapy. Patients are not exposed to additional risks compared to a substitution therapy outside of a study context, as there is extensive clinical experience with both medications and patients will be closely monitored.
Age
Inclusion criteria
- Age 18 or over.
- Meeting ICD-11 criteria for chronic (non-malignant) pain.
- Using a prescribed opioid with an oral morphine equivalent dose of over 60 mg per day for
≥3 months.
- Have an opioid use disorder according to the DSM-5 criteria.
- Wish to be treated for opioid use disorder.
- Willing to comply to study procedures.
- Be able to give informed consent.
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
Recruitment
IPD sharing statement
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9781 |
| CCMO | NL77333.091.21 |
| EudraCT | 2021-001817-35 |