NCT02158117

Brief Summary

Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

June 2, 2014

Last Update Submit

February 2, 2017

Conditions

Drug Overdose

Keywords

Emergency TreatmentMorphine DerivatesHeroinAntidotesAdministration, Intranasal

Outcome Measures

Primary Outcomes (1)

  • bioavailability of naloxone

    A LCMSMS method for determination of Naloxone in serum was developed using acetonitrile protein precipitation. Naloxone D5 was used as internal standard and quantitative determination was done by using Sciex Analyst version 1.5. The method is fully validated by assessing linearity, accuracy, precision, sensitivity, specificity/selectivity, in process and storage stability, dilution integrity and assay ruggedness according to Dadgar (1995) and Shah (1991). The method was found linear, accurate and precise across the dynamic range of 0.05 to 45 ng/ml. Limit of quantification (LOQ) was 0.05ng/ml with CV = 12.7% and inaccuracy \< 7.8% (n = 17). Quality Controls (QC) in middle (n=18) and upper (n=18) calibration range had CV \< 4.2% and inaccuracy \<8.2 %

    2 weeks

Secondary Outcomes (3)

  • Maximum serum concentration (Cmax)

    2 weeks

  • Time to maximum serum concentration (Tmax)

    2 weeks

  • adverse events

    2 weeks

Study Arms (1)

nasal naloxone

EXPERIMENTAL

8 and 16 mg/ml, comparator 1 mg/ml. Three daily occasions with at least 3 days washout between treatment (min 8 days).

Drug: nasal naloxone

Interventions

nasal naloxoneDRUG

one puff in one nostril with the subject is lying down

nasal naloxone

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Normal electrocardiogram (ECG)
  • Hemoglobin: male 13.4 - 17.0 g/dL, female 11,7- 15.3 g/dL
  • Creatinine: male 60- 105 micromol/L female 45- 90 micromol/L
  • ASAT: male 15- 45 U/L, female 15- 35 U/L
  • ALAT: male 10- 70 U/L female 10- 45 U/L
  • Gamma GT: male 10- 80 U/L female 10- 45 U/L
  • HCG normal under 3 ye/L

You may not qualify if:

  • Taking any medications including herbal medicines the last week prior to first treatment visit
  • History of drug abuse
  • History of prior drug allergy
  • Having any local nasal disease or nasal surgery or recent cold for the last week
  • Pregnancy
  • Fertile women not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper IUD, Sterilization) throughout the study period until their last visit.
  • Lactating women
  • Any reason why, in the opinion of the investigator, the patient should not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, Norway

Location

Related Publications (1)

  • Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Jansook P, Dale O. Pharmacokinetics of a new, nasal formulation of naloxone. Eur J Clin Pharmacol. 2017 May;73(5):555-562. doi: 10.1007/s00228-016-2191-1. Epub 2017 Jan 31.

    PMID: 28144724RESULT

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Toril A Nagelhus Hernes, phd prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 6, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

NO(1)