This study has been transitioned to CTIS with ID 2024-513924-41-01 check the CTIS register for the current data. The primary objective of this study is to compare effectivity of suboxone and methadone on reducing opioid misuse.Secondary objectives…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scores on the Current Opioid Misuse Measure (COMM) questionnaire after two
months, compared between both treatments.
Secondary outcome
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.
Background summary
Chronic non-cancer pain affects around 20% of the general population. An
increasing number of chronic pain patients are treated with opioids. About one
in three patients that regularly take opioids for pain meet the DSM-5 criteria
for an opioid use disorder (OUD). An OUD can be treated using an opioid
substitution therapy (OST), where a short-acting opioid is substituted by a
long acting opioid; buprenorphine/naloxone (suboxone) or methadone. OSTs
significantly reduce opioid (mis)use and dependency and have a positive effect
on analgesia and quality of life. It is currently unclear whether buprenorphine
or methadone is the most effective OST option in pain patients with
prescription opioid use. Both medications are already used in regular care. We
compare effectivity of both medications.
Study objective
This study has been transitioned to CTIS with ID 2024-513924-41-01 check the CTIS register for the current data.
The primary objective of this study is to compare effectivity of suboxone and
methadone on reducing opioid misuse.
Secondary objectives include comparing the effects of these two medications on
pain, well-being and medication use.
Study design
This is a prospective, randomized, open-label, clinical trial with two parallel
treatment arms.
Intervention
There are 2 interventions, each patient will participate in one intervention;
- Treatment with suboxone (buprenorphine/naloxone).
- Treatment with methadon.
Patients will be randomized from their current opioid treatment to suboxone or
methadone and treated according to regular care protocols.
Study burden and risks
- Risk: both medications will be used within their indication. Therefore, there
are no additional risks compared to treatment outside of a study context.
- Burden: de study measures will take time and can cause slight discomfort.
They consist of the following; 1) 4-5x times filling out a number of
questionnaires (taking 15 minutes the first 1-2 times, then 3x 30 minutes. 2)
Participation in quantitative sensory testing. Sensory thresholds will be
tested using thermic, mechanical (pressure) and electric stimuli. This can
cause discomfort and will be done 3x (60 minutes each). 3) Participation in
walking test, this can cause discomfort for patients who have limited mobility
(3x 10 minutes). 4) Giving urine samples (3x) and a saliva sample (1x). 5)
Participation in cognitive tests (3x 20 min) and a computertask
(Pavlovian-to-Instrumental Transfer task, 1x30 min).
- Benefits: none.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-513924-41-01 |
| EudraCT | EUCTR2021-001817-35-NL |
| CCMO | NL77333.091.21 |
| Other | NL9781 |