Opiate Antagonist OverdoseNCT02669901
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder
A study testing Naloxone Auto-Injector in people with Opiate Antagonist Overdose and Opioid-Related Disorders, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opiate Antagonist Overdose, Opioid-Related Disorders
- What is being tested?
- Naloxone Auto-Injector
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2016to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNM Hospitals - Alcohol and Substance Abuse Program
Albuquerque, New Mexico, 87106
About this study
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.
Read the 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.
- Being tested
- Naloxone Auto-Injector
- Keywords
- Opioid-Related Disorders, Naloxone, Harm Reduction, Drug Overdose Deaths, Opioid Misuse, Naloxone Coprescribing, Universal Precautions, Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Auto-InjectorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with opioid use disorder | Other | All participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose Receives: Behavioral: Naloxone Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program
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.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start4 Apr 2016
- Primary completion16 May 2017
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate Antagonist OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Kaleo Inc.
- Responsible party
- Principal investigator, Joanna G Katzman, University of New Mexico
- Investigators
- Joanna Katzman, MD, Principal investigator, University of New Mexico School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669901
- Sponsor's protocol ID
- 15-616
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2015
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We published our study results. Please refer to the following publications: PMID: 32101312 PMID: 32404109 PMID: 29227321 PMID: 32600618 PMID: 30303890
Publications
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.
PubMed 32101312
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT02669901
- Acronym / sponsor ID
- 15-616
- Keywords
- Opioid-Related Disorders, Naloxone, Harm Reduction, Drug Overdose Deaths, Opioid Misuse, Naloxone Coprescribing, Universal Precautions, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Kaleo Inc.
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with opioid use disorder | Other | Behavioral: Naloxone Auto-InjectorAll participants received Naloxone autoinjector as a preventative tool for accidental opioid overdose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone Auto-InjectorNaloxone 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. | Behavioural | Patients with opioid use disorder |
Primary outcome
To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program
Time frame: 1 year after enrollment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32101312Katzman 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.
- Individual participant dataSharing planned: No. We published our study results. Please refer to the following publications: PMID: 32101312 PMID: 32404109 PMID: 29227321 PMID: 32600618 PMID: 30303890
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Katzman, MD principal investigator
University of New Mexico School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naloxone Auto-Injector in people with Opiate Antagonist Overdose and Opioid-Related Disorders, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure the Association of Take-home Naloxone With Overdose Reversals Performed by Patients With Opioid Use Disorder Enrolled in an Opioid Treatment Program (time frame: 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.