A Phase 1 interventional study of Naloxone in Drug Overdose and Opioid-Related Disorders, sponsored by King's College London. Status unknown. Open to male participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by King's College London · Phase 1 and Interventional
Naloxone is the standard treatment in response to cases of suspected opiate overdose.
Buccal formulation of naloxone is a novel alternative to the licensed naloxone injection which, by removing the risk of accidental needle-stick, may be safer and easier to administer.
Current UK policy allows the emergency administration of naloxone by any member of the general public (Strang, Kelleher, Best, Mayet, \& Manning, 2006), and the preventative provision of naloxone to drug users and their family members ("take-home naloxone") is possible on a prescription basis. Thus, buccal naloxone may be particularly suitable for administration by family members who are providing interim overdose management care while awaiting the arrival of an ambulance.
The aim of this study is to examine the bioavailability and dose proportionality of buccal naloxone compared with the licensed injection standards (intravenous, intramuscular).
The investigators hypothesise that buccal naloxone is not inferior to the injection reference in absorption kinetics, i.e. time elapsed till peak concentration (Tmax; primary outcome), peak plasma concentration (Cmax), overall absorption (AUC), bioavailability (F%) and, duration of action (mean terminal half-life; T1/2).
The investigators propose a pharmacokinetic pilot investigation with within-subjects (crossover) design, comparing two doses (0.8 mg; 1.6 mg) of buccal naloxone hydrochloride solution to the licensed intramuscular (IM; 0.8 mg) and intravenous (IV; 0.8 mg) routes of injection. The investigators will invite four healthy (i.e., non-opioid using) male volunteers (n=4, not powered), each of whom will attend four experimental sessions at counterbalanced sequence. Each volunteer will receive naloxone hydrochloride doses of 0.8 mg IM, 0.8 mg IV, 0.8 mg buccal, and 1.6 mg buccal, with only one dose administered per session.
Blood concentrations will be measured at selected times during each session to establish speed of naloxone absorption, time to peak concentration, estimated half-life, and overall bioavailability. This dose-ranging pilot will inform future work by providing preliminary data on buccal naloxone absorption into the bloodstream and by establishing feasibility of the buccal route for naloxone delivery.
Blood samples (3 ml) will be collected at -5, +1, 2, 3, 4, 6, 8, 10, 12.5, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's planned enrollment of 4 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
0.8 mg buccal (solution) of 1 mg/ml Naloxone Hydrochloride Injection
Drug: Naloxone
1.6 mg buccal (solution) of 1 mg/ml Naloxone Hydrochloride Injection
Drug: Naloxone
0.8 mg IM injection of 1 mg/ml Naloxone Hydrochloride Injection
Drug: Naloxone
0.8 mg IV injection of 1 mg/ml Naloxone Hydrochloride Injection
Drug: Naloxone
Also known as: naloxone-hydrochloride
Tmax
Time elapsed till peak concentration
Time frame: Within 8-hour sampling period
Peak plasma concentration is assessed as Cmax
Peak concentration
Time frame: Within 8-hour sampling period
Absorption of the active ingredient is determined as Area under the Curve (AUC)
Overall absorption (AUC = Area Under the Curve)
Time frame: Within 8-hour sampling period
Absolute bioavailability of buccal naloxone relative to intravenous naloxone is assessed as F%
Absolute bioavailability relative to the IV reference (dose-corrected AUC for non-intravenous Buccal AUC divided by intravenous AUC multiplied by 100
Time frame: Within 8-hour sampling period
Mean terminal half-life is assessed for all participants as T1/2
mean terminal half-life
Time frame: Within 8-hour sampling period
No study locations are listed for this record.
Plan to share: Undecided — There is no plan to provide access to to raw data.
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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King's College London