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

March 26, 2024 updated by: M.D. Anderson Cancer Center

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jaya Amaram-Davila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (survey)
Participants complete a survey over 30 minutes.
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
Time Frame: Up to 1 year
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.
Time Frame: Up to 1 year
Up to 1 year
To determine the association between high risk patients' and their caregivers' characteristics
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jaya S Amaram-Davila, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

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)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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