Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

• Status: Terminated
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Hypoglycemic Agents; Insulin; Insulin, Globin Zinc; Naloxone

Criteria

Inclusion Criteria:

1. Subjects are capable of giving informed consent.

2. Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.

3. Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

1. Women who are pregnant.

2. Women who are breastfeeding.

3. Subject has a known hypersensitivity to naloxone.

4. Subject with hypertension

5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease

6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.

7. Subject has taken either prescribed or over the counter medication for 48 hours prior to study drug administration on either of the study days, other than hormonal birth control.

8. History of narcotic or heroin abuse.