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)
ConditionsAddiction to illicit heroinMedDRA version: 18.1Level: LLTClassification code 10019935Term: Heroin addictionSystem Organ Class: 100000004873MedDRA version: 18.1Level: LLTClassification code 10001127Term: Addiction to drugsSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
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.
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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