Treatment of opioid dependency in patients with chronic pain: a comparative study between suboxone and methadone.

Phase 1

• Conditions: Opioid use disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-001817-35-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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 90 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

- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To compare the effects of suboxone and methadone on well-being.<br>- To compare the effects of suboxone and methadone on drug use.<br>;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 Outcome Measures

Name	Time	Method
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.<br>Questionnaires: COMM, VAS-pain, BPI, CSI, VAS-QOL, WHOQOLBREF, DASS, VAS-craving, OCDS, GPE, ORSDS, FFMQ-SF, SCS, TCQ, CFQ. <br>Tests: quantitative sensory testing, 6-minutes walking test, urine toxicology, MoCA, 15WT, SCWT, PASAT.<br>Other: dose of drug, treatment retention.<br><br>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.