Community and Familial Impacts of the Opioid Crisis

NCT05116852 | Completed

• 1 other identifier: CHA-IRB-20-21-7
• Study Type: observational
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. Mental health status related to the death or support of a loved one will be assessed through a survey and through the use of several modules of the CAT-MH (computerized adaptive testing-mental health suite) questionnaire.

Conditions

Opioid Use Disorder; Bereavement; Overdose of Opiate

Outcome Measures

Primary Outcomes (1)

• Establish the percentage of adults who have lost a loved one to opioid overdose who had increased substance use in the year after their loss.

  This self-report aim will be assessed via participant survey response asking for recollection of substance use before and after the loss.

  Day 1

Secondary Outcomes (3)

• Establish the percentage of adults who have lost a loved one to opioid overdose who received mental health treatment in the year after their loss.

  Day 1

• Compare the level of negative impact on substance use and mental health status in the year after loss due to overdose with the impact on substance use and mental health in the year after becoming aware of a child's opioid addiction.

  Day 1

• Prolonged Grief

  Day 1

Other Outcomes (5)

• Depression

  Day 1

• Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening eating disorders, OCD (Obsessive-compulsive disorder), or problematic sexual behaviors in the year after their loss.

  Day 1

• Anxiety

  Day 1

Study Arms (3)

Both grieving a loved one to opioid-related death and have an actively using loved one

These individuals will complete the study survey for their designated experience both supporting a loved one in treatment for Opioid Use Disorder, and having lost a loved one to opioid-related death.

Other: Survey

Individuals supporting a loved one in treatment for Opioid Use Disorder

These individuals will complete the study survey for their designated experience supporting a loved one in treatment for Opioid Use Disorder.

Other: Survey

Individuals grieving a loved one to opioid-related death

These individuals will complete the study survey for their designated experience losing a loved one to opioid-related death.

Other: Survey

Interventions

Survey OTHER

All study participants will be asked to complete two surveys relevant to their personal experience either losing a loved one to opioid-related death, supporting a loved on in recovery for Opioid Use Disorder, or both.

Both grieving a loved one to opioid-related death and have an actively using loved one; Individuals grieving a loved one to opioid-related death; Individuals supporting a loved one in treatment for Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be selected by an email send both to collaborating organizations that provide peer support for those with addiction-related overdose and to healthcare systems that provide care for people with OUD to share with people in their communities who may have lost a loved one to opioid-related death.

You may qualify if:

• Aged 18+, inclusive, who are competent, wish to participate and willing to provide informed consent
• Willing and able to participate in completing the surveys using the internet on via smartphone as requested
• Identify in one of the 3 groups: (a) Adults who have lost a direct relative or friend to opioid overdose or opioid-related death prior to taking the survey; (2) Adults who are currently supporting a loved one with active opioid addiction; (3) Adults who have lost a direct relative or friend to opioid overdose or opioid related death at least six months prior to survey participation and also currently support a loved one in active addiction recovery.

You may not qualify if:

• Inability to complete the survey
• Inability to speak, read, and understand English

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• The Sandra and Arnold Gold Humanism Research Fund: collaborator

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 11, 2021
• Study Start: April 1, 2022
• Primary Completion: April 21, 2024
• Study Completion: June 21, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)