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Trial Outcomes & Findings for Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder (NCT NCT02669901)

NCT ID: NCT02669901

Last Updated: 2024-08-12

Results Overview

The study participants received 2 naloxone kits at their initial visit. They were educated on how to recognize the signs and symptoms of an OD, the importance of calling 911, rescue breathing techniques, and staying with the person experiencing the OD until medical help has arrived. They were asked about their use of naloxone every 3 months, including the situation of the naloxone kits, dose, and to whom they used.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

395 participants

Primary outcome timeframe

1 year after enrollment

Results posted on

2024-08-12

Participant Flow

Participant milestones

Participant milestones
Measure
Patients With Opioid Substance Abuse Disorders
All participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose.
Overall Study
STARTED
395
Overall Study
COMPLETED
336
Overall Study
NOT COMPLETED
59

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients With Opioid Substance Abuse Disorders
n=395 Participants
The study participants received 2 (two) 0.4 mg of naloxone auto-injectors (intramuscular injection). The participants were instructed to use the naloxone autoinjector when they witnessed an opioid overdose. Also, they were instructed to educate their bystanders on what opioid overdose is and asked them to use naloxone in case of their opioid overdose. The auto-injectors could be used twice if one injection was not sufficient for an opioid overdose.
Age, Continuous
35.4 years
STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male
Female
270 Participants
n=5 Participants
Sex: Female, Male
Male
125 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
16 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=5 Participants
Race (NIH/OMB)
White
360 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
n=5 Participants
Region of Enrollment
United States
395 Participants
n=5 Participants
Medication-assisted treatment
Methadone
279 Participants
n=5 Participants
Medication-assisted treatment
Buprenorphine
109 Participants
n=5 Participants
Medication-assisted treatment
Naltrexone (oral or intramuscular)
7 Participants
n=5 Participants
Companion for naloxone education
Present
33 Participants
n=5 Participants
Companion for naloxone education
Not present
354 Participants
n=5 Participants
Companion for naloxone education
Unknown
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 year after enrollment

Population: Study participants who completed at least 1 follow up visits.

The study participants received 2 naloxone kits at their initial visit. They were educated on how to recognize the signs and symptoms of an OD, the importance of calling 911, rescue breathing techniques, and staying with the person experiencing the OD until medical help has arrived. They were asked about their use of naloxone every 3 months, including the situation of the naloxone kits, dose, and to whom they used.

Outcome measures

Outcome measures
Measure
Patients With Opioid Use Disorder
n=336 Participants
All participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose.
To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program
Study participants who reported OD reversa
73 Participants
To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program
Study participants who reported no OD reversals
263 Participants

Adverse Events

Patients With Opioid Use Disorder

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanna Katzman, Principal Investigator

Univesity of New Mexico School of Medicine

Phone: (505) 272-2321

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place