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 heroi

Phase 1

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

• Registration Number: EUCTR2011-001088-28-GB
• Lead Sponsor: South London and Maudsley NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-10
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified