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Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02158117
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Drug Overdose Drug: nasal naloxone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nasal naloxone
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
one puff in one nostril with the subject is lying down




Primary Outcome Measures :
  1. bioavailability of naloxone [ Time Frame: 2 weeks ]
    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 %


Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) [ Time Frame: 2 weeks ]
  2. Time to maximum serum concentration (Tmax) [ Time Frame: 2 weeks ]
  3. adverse events [ Time Frame: 2 weeks ]
    will be reported from the start of the first session to the follow-up visit.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Fertile women must use safe contraception and have a negative serum HCG at inclusion

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158117


Locations
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Norway
Department of Circulation and Medical Imaging
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Toril A Nagelhus Hernes, phd prof Norwegian University of Science and Technology
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02158117    
Other Study ID Numbers: OPI-13-001
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Keywords provided by Norwegian University of Science and Technology:
Emergency Treatment
Morphine Derivates
Heroin
Antidotes
Administration, Intranasal
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents