Engaging service users in research design for a novel naloxone formulation for heroin overdose reversal

First published: March 29, 2019 | Last updated: May 20th, 2019

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Ms Rebecca McDonald

Rebecca McDonald is a second-year PhD student at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN). She is supervised by Professor John Strang and Professor David Taylor in a joint project of the Addictions Department and the Institute of Pharmaceutical Science at King’s College London. Her doctoral research examines novel injection-free naloxone formulations for the prevention of opiate overdose deaths, using pharmacokinetic trials in healthy volunteers and a low-dose dose-response trial in opioid-dependent service users to test the effectiveness of the novel formulations.

Rebecca has previously worked as a senior research assistant at the National Center on Addiction and Substance Abuse at Columbia University (U.S.), implementing Screening, Brief Intervention and Referral to Treatment (SBIRT) programs for harmful alcohol use in primary care and evaluating a medication-assisted treatment initiative for needle-exchange program participants without health insurance.  Rebecca holds a ”Diplom in Psychologie” (MSc equivalent) with concentration in clinical psychology and behavioural neuroscience from University of Marburg (Germany).

Work carried out: National Addiction Centre Institute of Psychiatry, Psychology & Neuroscience (IoPPN) I King’s College London Addictions Sciences Building, 4 Windsor Walk, Denmark Hill, London, SE5 8BB

Funding: MRC/Institute of Psychiatry Excellence Studentship Clinical trial reg: EudraCT Number: 2014-001802-16

Role: The notion of a buccal naloxone tablet was conceived by Professor John Strang who serves as PI on the project and is also my PhD supervisor.The prototype for the buccal naloxone tablet was developed by Abdulmalik Alqurshi, a PhD student at the King’s College Institute of Pharmaceutical Science.

My contribution to the buccal naloxone project is distinct: I have conducted the focus group sessions with user representatives and documented all findings (qualitative data).  Incorporating these findings, I have developed the study design for the three clinical trials that will be at the core of my PhD. I am responsible for the day-to-day management of the project and have processed all regulatory paperwork for ethics and MHRA clearance. Once we receive clearance, I will coordinate volunteer recruitment, carry out data collection, and conduct all statistical analyses.

Abstract: Aims: With heroin overdose deaths rising in the UK, the MHRA (2013) supports making naloxone directly accessible to opiate users and their families. By enabling family members to administer the life-saving antidote while awaiting an ambulance, take-home naloxone could significantly reduce overdose death rates. However, the necessary regulatory change to over-the-counter status remains unlikely for as long as naloxone is only available as injectable formulation.

The aims of this project are to 1) develop a novel injection-free naloxone formulation and 2) establish an ethically feasible research strategy to test the product for its potential to reverse opioid action.

Methods: In partnership with the KCL Institute of Pharmaceutical Science, we have developed a buccal naloxone tablet using freeze-drying technology.

Prior to testing in a currently dependent population, we convened focus groups with current service users (n=7) and user representatives (n=2) to design a research strategy to test the new tablet for clinical effectiveness without exposing participants to severe withdrawal symptoms.

Results: A research strategy comprising a series of first-in-man clinical trials was jointly developed. For proof-of-concept in opioid users, an RCT was dismissed in favour of an open-label dose-escalation design. Users’ views on the buccal tablet were recorded and demonstrate cautious acceptability.

Conclusion: Through active involvement of service users with personal overdose experience, we have developed a research strategy that is sufficiently rigorous and reasonable from a user’s perspective. We are currently awaiting regulatory clearance to begin data collection on the first of three clinical trials.

Co-Authors

Dr Jo Neale (King’s College London) Prof John Strang (King’s College London)

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Ms Rebecca McDonald