Trial to study the use of injectable buprenorphine in patients who persist in using illicit heroin to find an acceptable dose that could help reduce the use of illicit heroin

Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment - Buprenorphine Research into Injectable Opioids (BRIO)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001088-28-GB

Enrollment

Registered

2015-12-10

Start date

2016-01-14

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction to illicit heroin MedDRA version: 18.1 Level: LLT Classification code 10019935 Term: Heroin addiction System Organ Class: 100000004873 MedDRA version: 18.1 Level: LLT Classification code 10001127 Term: Addiction to drugs System Organ Class: 100000004873

Interventions

Trade Name: Temgesic Injection 1ml Product Name: Buprenorphine Pharmaceutical Form: Injection INN or Proposed INN: buprenorphine hydrochloride CAS Number: 53152-21-9 Concentration unit: mg/ml milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Aged 21-60 • Currently in sublingual buprenorphine treatment for a minimum of 1 week this episode, and for a total of 12 months on methadone or buprenorphine • Willing to attend for daily treatment • Written, Informed consent to participate • Persisting in injecting heroin > 3 days per week as evidenced by client self-report of regular injecting heroin use in the preceding 3 months, and of injecting heroin use on at least 50% of days in the past month • evidence of regular injecting on clinical examination • clinical formulation consistent with regular heroin use in the past 3 months, based on o Morphine positive urine samples o entries documented in clinical records, o examination findings documented in clinical records, •Can understand, read and speak English •Impaired health associated with chronic injecting (such as vein damage with impaired venous circulation, abscesses, HIV) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Pregnant, breastfeeding, or planning to become pregnant (subjects at risk of pregnancy must agree to use contraception while receiving injectable treatment); •Unable to attend the clinic daily; •Advanced liver disease (jaundice, ascites, encephalopathy); •Chronic airflow limitation, or other respiratory compromise producing dyspnea on mild exertion; •Currently facing charges likely to lead to imprisonment. •Cannot understand, speak or read English. •Known allergy to buprenorphine •Known hypersensitivity to any of the excipients. Precaution: •Current alcohol or benzodiazepine dependence – prospective participants may require detoxification prior to induction onto parenteral buprenorphine.

Design outcomes

Primary

Measure	Time frame
Main Objective: The trial aims to examine the safety, acceptability, and physiological responses to high dose injectable buprenorphine, for subjects not responding to their current maintenance treatment. The key outcomes are as follows: - Feasibility, of recruiting and maintaining subjects with a daily injection (IV/IM) of buprenorphine (successful retention outcome defined as 60+ %) - Reduction or cessation of injecting street heroin (successful outcome defined as 50% of urine tests negative for illicit heroin (i.e. morphine) in weeks 14-26) - Safety (of daily IV/IM injection of buprenorphine (assessed by observations of IMP administration, laboratory testing, cardio respiratory monitoring, and adverse events) ;Secondary Objective: -the subjective and physiological responses (e.g., perceived liking, withdrawal, efficacy, agonist effects) to daily injectable buprenorphine over a range of doses - the optimal dosage range for IV/IM buprenorphine treatment - ascertaining appropriate power calculations required to run a full randomised controlled trial ;Primary end point(s): Completion of 6 months prescribed injected buprenorphine. Reduction in heroin use. ;Timepoint(s) of evaluation of this end point: Dose change, 3 and 6 months	—

Measure

Time frame

Main Objective: The trial aims to examine the safety, acceptability, and physiological responses to high dose injectable buprenorphine, for subjects not responding to their current maintenance treatment. The key outcomes are as follows: - Feasibility, of recruiting and maintaining subjects with a daily injection (IV/IM) of buprenorphine (successful retention outcome defined as 60+ %) - Reduction or cessation of injecting street heroin (successful outcome defined as 50% of urine tests negative for illicit heroin (i.e. morphine) in weeks 14-26) - Safety (of daily IV/IM injection of buprenorphine (assessed by observations of IMP administration, laboratory testing, cardio respiratory monitoring, and adverse events) ;Secondary Objective: -the subjective and physiological responses (e.g., perceived liking, withdrawal, efficacy, agonist effects) to daily injectable buprenorphine over a range of doses - the optimal dosage range for IV/IM buprenorphine treatment - ascertaining appropriate power calculations required to run a full randomised controlled trial ;Primary end point(s): Completion of 6 months prescribed injected buprenorphine. Reduction in heroin use. ;Timepoint(s) of evaluation of this end point: Dose change, 3 and 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Investigation of subjective and physiological responses to injectable buprenorphine across a range of doses;Timepoint(s) of evaluation of this end point: Dose change, 3 and 6 months	—

Countries

United Kingdom

Contacts

Public ContactProfessor John Strang

South London and Maudsley NHS Foundation Trust

john.strang@kcl.ac.uk004402078480819

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026