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

NCT04129138 | Active Not Recruiting

• 2 other identifiers: 2019-0330NCI-2019-06740
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver; Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Observational (survey)

Participants complete a survey over 30 minutes.

Other: Survey Administration

Interventions

Survey Administration OTHER

Complete survey

Observational (survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients prescribed naloxone in the last year and their caregivers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Jaya S Amaram-Davila, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: July 18, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)