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

A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caregiver; Patient
• Intervention / Treatment: Other: Survey Administration

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients prescribed naloxone in the last year and their caregivers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey); Participants complete a survey over 30 minutes.	Other: Survey Administration; Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.	Up to 1 year
To determine the association between high risk patients' and their caregivers' characteristics	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jaya S Amaram-Davila, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drug Overdose; Prescription Drug Misuse; Opioid-Related Disorders; Opiate Overdose
• Other Study ID Numbers: 2019-0330 (Other Identifier: M D Anderson Cancer Center); NCI-2019-06740 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No