Opiod addiction MedDRA version: 23.1 Level: LLT Classification code 10013658 Term: Drug addiction System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Sublocade
Product Code: RBP-6000
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Current Sponsor code: RBP 6
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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. 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: 1. Clinically significant medical condition or observed abnormalities on physical examination or laboratory investigation, including but not limited to: (a) 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; (b) severe alcohol dependence/withdrawal syndrome which is judged to be clinically significant and may constitute a risk to the patient's safety; (c) 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; 2. History of allergic or adverse reactions to Bup or the proprietary ATRIGEL delivery system for XR-Bup (Sublocade®)*; 3. 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; *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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To explore study group differences on the following measures: (1) Clinical superiority of XR-Bup plus personalised Psychosocial Intervention (PSI; offered across the treatment phase) versus Bup/Met plus PSI; (2) Safety of XR-Bup; (3) Treatment retention; (4) OUD remission status; (5) Clinician rated impression of patient response to treatment; (6) Patient reported recovery outcomes; (7) Mediation of craving, work and social adjustment, and cognitive function on outcome. Subject to securing research support, there will be implementation of a health economic analysis plan and analysis of data-registry indicators of mortality, convictions and health service utilisation (the later longer-term research aims). In preparation for this, participants will be asked for their consent.;Primary end point(s): Primary: 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.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Clinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI using the primary outcome measure; (2) Safety measured by all adverse event reporting; (3) Time (days) enrolled in study treatment (retention) to week 24; (4) OUD remission status (severity) measured by SCID-5-RV for DSM5; (5) Clinician rating of severity, complexity and recovery strengths (ADAPT); (6) Clinician rating of global impression (CGI-I anchored on baseline severity [CGI-S]); (7) 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; (8) Craving for opioids and cocaine (CEQ-F[H] and CEQ-F[C]); (9) VAS-N and VAS-W craving need for heroin and cocaine; (10) Difficulties in Emotion Regulation – Short Form (DERS-SF); (11) QIDS-SR (depression rating); (12) WSAS (work and social adjustment); (13) Subjective recovery and improvement (SURE); (14) Subjective rating of OUD improvement (PRO-I; on baseline severity [PRO-S); (15) Cognitive impairment (MoCA); (16) Alcohol: typical quantity and frequency (ALC-QFM) (17) Time (days) enrolled in study treatment (retention) from week 24 to date last participant randomised plus 9 months. ;Timepoint(s) of evaluation of this end point: 24 Weeks However those who optionally consent to extension phase will be Time (days) enrolled in study treatment (retention) from week 24 to date last participant randomized plus 9 months. | — |
Countries
United Kingdom
Contacts
Public ContactDr. Mike Kelleher
South London and Maudsley NHS Foundation Trust
Outcome results
None listed