Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial.

Phase 4

Recruiting

Conditions: dependence on opioids
opioid use disorder
10037176

Registration Number: NL-OMON52187

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Age 18 or over.
- Meet ICD-11 criteria for chronic 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 their 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Scores on the Current Opioid Misuse Measure (COMM) questionnaire after two<br /><br>months, compared between both treatments. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The mean scores on the following measures, compared between both treatments<br /><br>from baseline to two and six months after initiation of treatment.<br /><br>Questionnaires: COMM, VAS-pain, BPI, CSI, VAS-QOL, WHOQOLBREF, DASS,<br /><br>VAS-craving, OCDS, GPE, ORSDS, FFMQ-SF, SCS, TCQ, CFQ.<br /><br>Tests: quantitative sensory testing, 6-minutes walking test, urine toxicology,<br /><br>MoCA,15WT, SCWT, PASAT.<br /><br>Other: dose of drug, treatment retention.<br /><br><br /><br>We will also ask patients to fill the SOAPP-R, SR-MAD and ORT questionnaires,<br /><br>to validate these questionnaires. A genetic sample will be taken to study<br /><br>whether genetic data can predict treatment outcomes. </p><br>