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
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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ACTIVE_NOT_RECRUITING
182 participants
OBSERVATIONAL
2020-07-18
2026-06-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (survey)
Participants complete a survey over 30 minutes.
Survey Administration
Complete survey
Interventions
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Survey Administration
Complete survey
Eligibility Criteria
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Inclusion Criteria
* 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: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of \> 6
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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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
Countries
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Related Links
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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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