Buprenorphine Research into Injectable Opioids BRIO

  • Research type

    Research Study

  • Full title

    Feasibility, efficacy and acceptability of intravenous buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment

  • IRAS ID

    73366

  • Contact name

    John Strang

  • Contact email

    john.strang@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Eudract number

    2011-001088-28

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    Opioid substitution treatment (OST) of heroin addiction involves prescription of opioids in monitored, structured treatment settings by substituting illicitly obtained heroin. OST involving prescription of methadone or buprenorphine attracts and retains a higher proportion of heroin users than other treatment modalities and while users remain in treatment they have reduced death risk, health problems, involvement in crime (Bell, 1997), improved psychological and social functioning (Bell and Zador, 2002).

    Not everyone responds to prescribed methadone or buprenorphine. Current UK policy allows "treatment failures" - people on methadone who persist with use of street heroin - to receive injectable diamorphine, along with oral methadone, in an attempt to stabilise patients. This treatment option is not currently open to people on sublingual buprenorphine, who would have to switch to oral methadone before entering injectable treatment.

    As a partial agonist, buprenorphine has a flattened dose-response curve, and the maximal opioid effect achieved is self limiting. Compared to diamorphine, daily administration of IV buprenorphine is hypothesised to achieve slower, smaller increments in opioid activity.

    The hypothesis we are testing is whether maintenance on IV buprenorphine is sufficiently reinforcing for persisting illicit users to remain in treatment, without the need for non-prescribed injecting.

    We propose that it may be easier for patients (who stabilise on IV buprenorphine) to return to sublingual treatment than for those maintained on full agonist drugs.

    This study aims to examine the efficacy of IV buprenorphine & the potential for a randomised controlled trial by examining:
    - the feasibility of recruiting & maintaining people with a single daily injection of buprenorphine;
    - subjective & physiological responses (e.g., perceived liking, quality of life, withdrawal) to daily IV buprenorphine over a range of doses;
    - the optimal dosage range;
    - user & healthcare professionals' attitudes & perceptions of IV buprenorphine.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    13/LO/0814

  • Date of REC Opinion

    27 Jun 2013

  • REC opinion

    Further Information Favourable Opinion