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NCT Number: NCT04129138

Patient and Caregiver Attitudes and Beliefs Regarding 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Complete survey

Primary outcomes

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

    Time frame: Up to 1 year

Secondary outcomes

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

    Time frame: Up to 1 year

  2. To determine the association between high risk patients' and their caregivers' characteristics

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2019
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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