Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose

NCT ID: NCT04129138

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-18

Study Completion Date

2026-06-30

Brief Summary

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This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them.

SECONDARY OBJECTIVES:

I. To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.

II. To determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye \[CAGE\], screener and opioid assessment for patients with pain \[SOAPP\], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for Narcan prescription, health insurance, and setting of Narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients.

EXPLORATORY OBJECTIVE:

I. To conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray.

OUTLINE:

Participants complete a survey over 30 minutes.

Conditions

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Caregiver Patient

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (survey)

Participants complete a survey over 30 minutes.

Survey Administration

Intervention Type OTHER

Complete survey

Interventions

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Survey Administration

Complete survey

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must have been prescribed intranasal naloxone in the past 1 year
* Patients and caregivers must be able to understand, read, write, and speak English
* Patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (Memorial Delirium Assessment Scale score of \>= 7)
* Patients must sign an informed consent
* Caregivers may sign an informed consent if available during the visit
* Caregivers may verbally consent over the phone if not present during the visit
* Caregiver must be a friend, significant other or family member
* Caregivers must have no evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place

Exclusion Criteria

* PATIENT: Emotional or psychosocial distress as identified by the patient's palliative care
* PATIENT: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of \> 6
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaya S Amaram-Davila, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-06740

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-0330

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0330

Identifier Type: -

Identifier Source: org_study_id

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