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Clinical Trials/EUCTR2011-001088-28-GB
EUCTR2011-001088-28-GB
Active, not recruiting
Phase 1

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)

South London and Maudsley NHS Foundation Trust0 sites10 target enrollmentDecember 10, 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Addiction to illicit heroin
Sponsor
South London and Maudsley NHS Foundation Trust
Enrollment
10
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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,

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.

Outcomes

Primary Outcomes

Not specified

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