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Opiate Substitution TreatmentPhase 3EXPONCT05164549

Extended-release Pharmacotherapy for Opioid Use Disorder

A Phase 3 study testing Buprenorphine Injectable Product, Methadone and Buprenorphine in people with Opiate Substitution Treatment, run by King's College London at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is a clinical superiority effectiveness contrast to standard of care. Reported following SPIRIT and CONSORT standards, the study will determine whether extended-release injectable depot Buprenorphine (XR-Bup) maintenance therapy for OUD over six months is clinically superior to standard-of-care… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opiate Substitution Treatment
What is being tested?
Buprenorphine Injectable Product, Methadone and Buprenorphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
5 sitesUnited Kingdom
Study dates
6 Aug 2019to 1 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

IInclusion criteria

  1. Aged ≥ 18 years (no upper age limit);
  2. Current diagnosis of DSM-5 OUD via SCID-5-RV (moderate-severe at baseline for current episode);
  3. Currently enrolled on Met (30mg/day or less) or sublingual Bup or Bup-NX (24mg/day or less) or Esp (18mg/day or less) and in the view of the clinician would be able to convert to XR-Bup within 7 days post randomisation;
  4. Voluntarily seeking treatment and able to attend the clinic as required in the protocol;
  5. Able to communicate in English to level required to accept standard care and psychosocial intervention;
  6. Possession of a contactable personal mobile phone or landline telephone number and ability to nominate at least one locator individual with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments;
  7. Living circumstances judged to be of sufficient stability to be able to engage/adhere to the study protocol;
  8. Is not pregnant (confirmed) or breast feeding and, if currently or intending to have potentially procreative intercourse, agrees to use a birth control method (either oral hormonal contraceptives, barrier [condom or diaphragm], or Nexplanon implant) for the duration of the study.

8.2 Exclusion criteria

  1. Clinically significant medical condition or observed abnormalities on physical examination or laboratory investigation, including but not limited to:
  2. uncontrolled hypertension, significant heart disease (including angina and myocardial infarction in past 12 months), or any cardiovascular abnormality which is judged to be clinically significant;
  3. severe alcohol dependence/withdrawal syndrome which is judged to be clinically significant and may constitute a risk to the patient's safety;
  4. acute hepatitis taken as clinical jaundice on examination, or evidence of blood bilirubin level above the normal range for local reference criteria, or evidence of serum levels of aspartate aminotransferase, alanine aminotransferase levels that are more than three-times the upper limit of the normal range;
  5. History of allergic or adverse reactions to Bup or the proprietary ATRIGEL delivery system for XR-Bup (Sublocade®)*;
  6. Clinically significant or uncontrolled mental health problems (including but not limited to psychosis, bipolar disorder, schizoaffective disorder), or history or evidence of organic brain disease or dementia that may compromise safety or compliance with the study protocol;
  7. Current (past 30 day) suicide plan or suicide attempt in past six months;
  8. Current criminal justice involvement with legal proceedings, which in the opinion of a medically qualified investigator indicates a risk that the patient would fail to complete the study protocol due to re-incarceration or move away from the centre's catchment area.
  9. Currently taking oral or depot naltrexone therapy or enrolment in any form of naltrexone therapy within 90 days prior to study screening;
  10. Any contraindication to Bup*.
  • Participant is ineligible if they have any allergic or adverse reactions or contraindication to Buprenorphine. If participant has any allergic or adverse reaction or contraindication to Met or naloxone, or excipients of Bup-NX or Esp they can be prescribed Bup within the trial.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Birmingham and Solihull Mental Health NHS Foundation Trust

    Birmingham

  • NHS Tayside

    Dundee

  • South London and Maudsley NHS Foundation Trust

    London

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester

  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

    Newcastle upon Tyne

Other trials in United Kingdom

About this study

Official title: Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): Protocol for an Open-label Randomised Controlled Trial of Injectable Maintenance Buprenorphine With Personalised Psychosocial Intervention.

The primary objective is a clinical superiority effectiveness contrast to standard of care. Reported following SPIRIT and CONSORT standards, the study will determine whether extended-release injectable depot Buprenorphine (XR-Bup) maintenance therapy for OUD over six months is clinically superior to standard-of-care, oral medication (sublingual Buprenorphine [SL-Bup] or oral methadone [Met]; together: Bup/Met)

Read the detailed description

EXPO is a pragmatic, multi-centre, open label, four-arm, parallel group, superiority RCT, with a qualitative (mixed-methods) evaluation. The objective of the study is to determine the effectiveness and cost-effectiveness of XR-BUP versus SOC SL-BUP or MET. The primary study endpoint is six months of study treatment. EXPO also contains a single-site evaluation of the effectiveness of XR-BUP with adjunctive PSI versus SOC with adjunctive PSI. Participants allocated to XR-BUP can request to receive longer-term treatment for the duration of the study.

The study population is adults (≥18 years) enrolled in standard-of-care medication treatment for OUD. The study setting is specialist community addiction treatment programmes operated by the National Health Service in England and Scotland. There will be five participant treatment sites in South-East England (South London); North-East England (Newcastle); West Midlands, England (Solihull and Wolverhampton); North-West England (Manchester), and Tayside, Scotland (Dundee).

Groups

In all sites, participants will be randomly allocated to one of two groups:

Group 1. Injectable medication for OUD for 24 weeks (XR-BUP; the experimental condition) Group 2. Oral medication for OUD for 24 weeks (SL-BUP or MET; the control condition).

At the EXPO co-ordinating centre in South London, there will also be random allocation of participants to two additional groups, as follows:

Group 3. Injectable medication for OUD with adjunctive PSI for 24 weeks (XR-BUP with PSI; the experimental condition)

Group 4. Oral medication for OUD with adjunctive PSI for 24 weeks (SL-BUP or MET with PSI; the control condition).

Study aims

Across 24-weeks of study treatment, the primary aim of the EXPO study is to determine:

  1. The effectiveness and cost-effectiveness of XR-BUP versus SL-BUP or MET; and
  2. The effectiveness of XR-BUP with PSI versus SL-BUP or MET with PSI.

Across 24-weeks of study treatment, secondary study aims will determine the:

  1. Safety of XR-BUP;
  2. Retention of XR-BUP; SL-BUP; MET; XR-BUP with PSI; and SL-BUP or MET with PSI;
  3. Effectiveness of XR-BUP and SL-BUP and MET to reduce opioid craving;
  4. Effectiveness of XR-BUP; SL-BUP; MET; XR-BUP with PSI; SL-BUP with PSI; and MET with PSI to reduce use of heroin, cocaine, and benzodiazepines;
  5. Effectiveness of XR-BUP and SL-BUP and MET to improve social functioning and recovery.
  6. Cost-effectiveness of XR-BUP versus SL-BUP and MET, based on the incremental cost per quality-adjusted life year (QALY) gained.

Study aims will be evaluated by following a pre-registered statistical and health economic analysis plan.

Being tested
Buprenorphine Injectable Product, Methadone, Buprenorphine
Keywords
opiate, opioid, opioid treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine Injectable ProductDrug

    Also called Sublocade®; prev. RBP-60000

    Investigational Medicinal Product

  • MethadoneDrug

    Standard of Care

  • BuprenorphineDrug

    Also called Suboxone, Espranor, Subutex

    Standard of Care

Study groups in NCT05164549
Study groupRoleWhat they receive
XR-BupExperimentalExtended-Release Buprenorphine, monthly, 300mg or 100mg
Receives: Drug: Buprenorphine Injectable Product
Bup/MetActive comparatorStandard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference).
Receives: Drug: Methadone; Drug: Buprenorphine
XR-Bup + PSIExperimentalExtended-Release Buprenorphine, monthly, 300mg or 100mg + Personalised Psychosocial Intervention (PSI)
Receives: Drug: Buprenorphine Injectable Product
Bup/Met + PSIActive comparatorStandard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference) + Personalised Psychosocial Intervention (PSI)
Receives: Drug: Methadone; Drug: Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days)

    Combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens.

    Measured: 24 weeks

Secondary outcomes (23)

  1. Clinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI

    Number of days abstinent from cocaine Days 8 - 168 Number of days abstinent from Benzodiazepines Days 8 - 168 Longest time in days continuously abstinent from heroin Days 8 - 168 Longest time in days continuously abstinent from cocaine Days 8 - 168 Longest time in days continuously abstinent from Benzodiazepines Days 8 - 168

    Measured: 24 weeks

  2. Cost-effectiveness of XR-BUP versus Bup and Met

    Based on the incremental cost per quality-adjusted life year (QALY) gained.

    Measured: 24 weeks

  3. Safety of XR-Bup

    Number of safety events from study enrolment to 24 weeks

    Measured: 24 weeks

  4. Time (days) enrolled in study treatment (retention) to week 24

    Measured: 24 weeks

  5. OUD remission status (DSM5 OUD severity; SCID-5-RV)

    Measured: 24 weeks

  6. Clinician rating of severity, complexity and recovery strengths: ADAPT

    Measured: 24 weeks

  7. Clinician global impression of severity and improvement): CGI-S/I;

    Measured: 24 weeks

  8. Count of days abstinent from cocaine and illicit/non-medical benzodiazepines

    During weeks 2 to 24 (range: 0-161 days); combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens

    Measured: 24 weeks

  9. Frequency of opioid (H) and cocaine (C) craving experience: CEQ-F(H) and CEQ-F(C)

    Measured: 24 weeks

  10. Craving need and want strength for heroin and cocaine: VAS-N(H/C) and VAS-W(H/C)

    Measured: 24 weeks

  11. Difficulties in Emotion Regulation (Short Form): DERS-SF

    Measured: 24 weeks

  12. Depression symptoms: QIDS-SR

    Measured: 24 weeks

  13. Work and social adjustment: WSAS

    Measured: 24 weeks

  14. Subjective recovery and improvement: SURE

    Measured: 24 weeks

  15. Patient rating of OUD severity and improvement:

    Utilising PRO-S/I;

    Measured: 24 weeks

  16. Patient rating of OUD severity and improvement:

    Cognitive impairment: MoCA

    Measured: 24 weeks

  17. Alcohol consumption: typical quantity and frequency: (ALC-QFM)

    Measured: 24 weeks

  18. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: heroin, cocaine and illicit/non-medical benzodiazepine use in past 90 days (TLFB; UDS)

    Measured: Through study completion, up to 4 years

  19. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: OUD and CUD remission status (SCID-5-RV)

    Measured: Through study completion, up to 4 years

  20. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: somatic symptoms (PHQ-15)

    Measured: Through study completion, up to 4 years

  21. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: emotion regulation (DERS-SF)

    Measured: Through study completion, up to 4 years

  22. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: depression and anxiety symptoms (PHQ-4)

    Measured: Through study completion, up to 4 years

  23. Longer Term Outcomes

    Among participants enrolled in longer term XR-BUP treatment: quality of life (OSTQOL)

    Measured: Through study completion, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start6 Aug 2019
  3. Primary completion29 Apr 2022
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164549
Sponsor's protocol ID
255522
Acronym
EXPO
Status last verified
Oct 2021
First submitted
27 Oct 2021
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marsden J, Kelleher M, Hoare Z, Hughes D, Bisla J, Cape A, Cowden F, Day E, Dewhurst J, Evans R, Hearn A, Kelly J, Lowry N, McCusker M, Murphy C, Murray R, Myton T, Quarshie S, Scott G, Turner S, Vanderwaal R, Wareham A, Gilvarry E, Mitcheson L. Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone. Trials. 2022 Aug 19;23(1):697. doi: 10.1186/s13063-022-06595-0.

    PubMed 35986418

  • Marsden J, Kelleher M, Gilvarry E, Mitcheson L, Bisla J, Cape A, Cowden F, Day E, Dewhurst J, Evans R, Hardy W, Hearn A, Kelly J, Lowry N, McCusker M, Murphy C, Murray R, Myton T, Quarshie S, Vanderwaal R, Wareham A, Hughes D, Hoare Z. Superiority and cost-effectiveness of monthly extended-release buprenorphine versus daily standard of care medication: a pragmatic, parallel-group, open-label, multicentre, randomised, controlled, phase 3 trial. EClinicalMedicine. 2023 Nov 17;66:102311. doi: 10.1016/j.eclinm.2023.102311. eCollection 2023 Dec.

    PubMed 38045803

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buprenorphine Injectable Product, Methadone and Buprenorphine in people with Opiate Substitution Treatment, run by King's College London at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164549, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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