Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia (NCT02700048) | Clinical Trial Compass
TerminatedPhase 1/2
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
Stopped: research grant for the trial was not funded
United States11 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects are capable of giving informed consent.
✓. 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.
✓. 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
✕. Women who are pregnant.
✕. Women who are breastfeeding.
✕. Subject has a known hypersensitivity to naloxone.
✕. Subject with hypertension
✕. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
What they're measuring
1
Within Person Difference in Peak Epinephrine During Hypoglycemia
. Subject has taken or used any investigational drug or device in the 30 days prior to screening.
✕. 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.