EUCTR2011-001088-28-GBActive, not recruitingPhase 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 enrollmentStarted: December 10, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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