E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Addiction to illicit heroin |
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E.1.1.1 | Medical condition in easily understood language |
Addiction to illicit heroin |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019935 |
E.1.2 | Term | Heroin addiction |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001127 |
E.1.2 | Term | Addiction to drugs |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The trial aims to examine the safety, acceptability, and physiological responses to high dose injectable buprenorphine, for subjects not responding to their current maintenance treatment. The key outcomes are as follows:
- Feasibility, of recruiting and maintaining subjects with a daily injection (IV/IM) of buprenorphine (successful retention outcome defined as 60+ %)
- Reduction or cessation of injecting street heroin (successful outcome defined as 50% of urine tests negative for illicit heroin (i.e. morphine) in weeks 14-26)
- Safety (of daily IV/IM injection of buprenorphine (assessed by observations of IMP administration, laboratory testing, cardio respiratory monitoring, and adverse events) |
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E.2.2 | Secondary objectives of the trial |
-the subjective and physiological responses (e.g., perceived liking, withdrawal, efficacy, agonist effects) to daily injectable buprenorphine over a range of doses
- the optimal dosage range for IV/IM buprenorphine treatment
- ascertaining appropriate power calculations required to run a full randomised controlled trial
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Completion of 6 months prescribed injected buprenorphine.
Reduction in heroin use.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Dose change, 3 and 6 months |
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E.5.2 | Secondary end point(s) |
Investigation of subjective and physiological responses to injectable buprenorphine across a range of doses |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Dose change, 3 and 6 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient completing their last follow up visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |