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

NCT ID: NCT02669901

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-04
• Study Completion Date: 2020-08-20

Brief Summary

The purpose of this pilot-study is to to distribute naloxone auto-injector in a "Universal Precaution" manner to patients with opioid substance use disorder. The objectives are to decrease the number of fatal and nonfatal overdose deaths, to examine and understand the risk factors for serious opioid toxicity and overdose, and to evaluate the unintentional opioid overdose risk utilizing an evidence-based screening questionnaire.

Detailed Description

Between April 4, 2016, and May 16, 2017, 395 study participants voluntarily enrolled at the UNM ASAP for this prospective cohort study. The study closed 1 year after enrollment, on May 17, 2018. These study participants were current patients of the University of New Mexico's Addiction and Substance Abuse Program.

This study was approved by the University of New Mexico Human Research and Review Committee and was registered in the National Institutes of Health Clinical Trials (ClinicalTrials.gov Identifier NCT02669901). A certificate of confidentiality is on record at the National Institutes of Health for this study. Written informed consent was obtained from each individual study participant. This study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

Each study participant completed the initial visit and at least 1 follow-up visit. Inclusion criteria included history of OUD treated with methadone, buprenorphine, or naltrexone and age 18 years or older. Exclusion criteria included allergy to naloxone and age younger than 18 years.

The UNM ASAP is a federally qualified opioid treatment program (OTP) that provides medication-assisted treatment and behavioral therapy for adults, including pregnant women, as well as adolescents. Approximately 65% of the UNM ASAP patients are women. Most (80%) of the patients had previously used heroin (compared with prescription opioids) as their drug of choice before beginning medication-assisted treatment.

Initial Visit Data Collection At the initial visit, study participants provided demographic data, social history, limited medical history, type of medication-assisted treatment, medication list, and history of illicit drug use.21 All 395 study participants enrolled were evaluated to determine whether they had received a naloxone prescription in the year before enrollment. First, each participant's electronic medical record was queried to see whether a prescription for naloxone was written in the year before study enrollment. Second, every study participant was personally asked by the research coordinator at the initial study visit whether they had directly received a naloxone prescription in the year before enrollment.

OD Education and Naloxone Distribution During the initial visit, the study participant along with his or her companion, if present, were provided with OD information and learned the importance of using naloxone. Study participants were encouraged, but not required, to bring a companion to the visit. The education included recognizing 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. The research coordinator distributed 1 naloxone kit (2 doses) to study participants after they felt confident with using the naloxone autoinjector.21,22 Study participants were informed that they could return to the clinic to obtain a naloxone replacement kit if needed.

Quarterly Follow-up Visits Every 3 months, study participants were asked to follow up with the study coordinator to report on whether an OD reversal was performed and whether naloxone replacement kits were needed. Study participants could also obtain naloxone replacement kits Monday through Friday during clinic hours (7 am to 5 pm). Urine toxicology screens were obtained as part of the routine UNM ASAP clinic procedure and were reported previously.23

Statistical Analysis Stata statistical software version 15 (Stata Corp) was used for all analyses, including distributions of study participants' characteristics at the initial visit, relationships between community members for whom OD reversal was performed and study participants, number of OD reversals performed, and reasons for replacement of THN kits. Stata 15 was also used for χ2 tests for statistical significance of associations between companion attendance at initial opioid education and performing at least 1 OD reversal. One-sided P < .05 was considered statistically significant. Data analysis was performed from May 2018 to July 2019.

Conditions

Opiate Antagonist Overdose; Opioid-Related Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients with opioid use disorder

All participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose

Group Type: OTHER

Naloxone Auto-Injector

Intervention Type: BEHAVIORAL

Naloxone auto-injector is FDA approved and labeled for use by family members or caregivers for emergency therapy and rescue wherever opioids are present. Bystanders of patient are able to provide naloxone when drug overdose occurs.

Interventions

Naloxone Auto-Injector

Naloxone auto-injector is FDA approved and labeled for use by family members or caregivers for emergency therapy and rescue wherever opioids are present. Bystanders of patient are able to provide naloxone when drug overdose occurs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patients treated with methadone, naltrexone or buprenorphine as medication assisted treatment at the UNM Addiction and Substance Abuse Program (UNM ASAP) aged 18 or older

Exclusion Criteria

• Subjects who are allergic to naloxone and its inactive ingredients. Inactive ingredients include buffering agents.
• Subjects younger than 18.
• Subjects not being treated at UNM ASAP.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaleo Inc.

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Joanna G Katzman

Dr. Joanna Katzman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna Katzman, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico School of Medicine

Locations

UNM Hospitals - Alcohol and Substance Abuse Program

Albuquerque, New Mexico, United States

Countries

United States

References

Katzman JG, Takeda MY, Greenberg N, Moya Balasch M, Alchbli A, Katzman WG, Salvador JG, Bhatt SR. Association of Take-Home Naloxone and Opioid Overdose Reversals Performed by Patients in an Opioid Treatment Program. JAMA Netw Open. 2020 Feb 5;3(2):e200117. doi: 10.1001/jamanetworkopen.2020.0117.

Reference Type: BACKGROUND

PMID: 32101312 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-616

Identifier Type: -

Identifier Source: org_study_id