ClinicalTrials.gg
CompletedNCT05116852Updated Jul 4, 2025

Community and Familial Impacts of the Opioid Crisis

An observational study in Opioid Use Disorder, Bereavement and Overdose of Opiate, sponsored by Cambridge Health Alliance. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by Cambridge Health Alliance · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
578
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study aims to establish the level of needs in the community among those who have lost loved ones to opioid overdose and/or currently support those in opioid addiction recovery. 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. The study will evaluate the mental health status for each study participant through a primary survey as well as current participant mental health status through the use of several modules of the CAT-MH adaptive testing questionnaire. CAT-MH will be used to rapidly measure severity levels of depression, anxiety, and substance use risk after participants complete the primary survey. The primary survey assesses the immediate impact of overdose death by a loved one and recognition of the onset of opioid addiction in the years after the event on family and community members. The primary survey will compare the impact of loss and/or recovery support on mental health and substance use at specified time points before and after the loss and/or an individual finding out about a loved one's opioid addiction. The primary survey will also evaluate attitudes in this population about mindfulness and self-compassion skills training, openness to technology and various treatment options, current and past levels of depression, anxiety and grief, as well as thematic areas of need specific to those who have lost a loved one to opioid overdose and/or currently support a loved one in opioid addiction recovery.

02

Conditions studied

  • Opioid Use Disorder
  • Bereavement
  • Overdose of Opiate
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 578 is above the median of 129 across 184 observational studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18+, inclusive, who are competent, wish to participate and willing to provide
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Inability to complete the survey
  • Inability to speak, read, and understand English
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
578 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSurvey

    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.

06

What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

  1. 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.

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

    Time frame: Day 1

  2. 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.

    This aim will be assessed via participant survey response between cohorts

    Time frame: Day 1

  3. Prolonged Grief

    Aa version of the prolonged grief (PG-13) scale will be used to assess presence of prolonged grief after date of loss event.

    Time frame: Day 1

Other outcomes

  1. Depression

    This aim will be assessed via CAT-MH's CAT-DI adaptive test (computerized adaptive testing-mental health suite for depression).

    Time frame: Day 1

  2. 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.

    This aim will be assessed via participant survey self-report responses.

    Time frame: Day 1

  3. Anxiety

    This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test

    Time frame: Day 1

  4. PTSD symptoms

    This aim will be assessed via CAT-MH's CAT-PTSD adaptive test

    Time frame: Day 1

  5. Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening depression in the year after their loss.

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

    Time frame: Day 1

07

Study locations

1 site
  • Cambridge Health Alliance
    Cambridge, Massachusetts 02141, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Apr 2024, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2021
First posted
Nov 11, 2021
StartActual
Apr 1, 2022
Primary completionActual
Apr 21, 2024
CompletionActual
Jun 21, 2024
Last update
Jul 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05116852
Lead sponsor
Cambridge Health Alliance
Collaborators
The Sandra and Arnold Gold Humanism Research Fund
Responsible party
Zev Schuman Olivier (Assistant Professor, Psychiatry, Cambridge Health Alliance) — Principal investigator
First posted
Nov 11, 2021
Start date
Apr 1, 2022
Primary completion
Apr 21, 2024
Completion
Jun 21, 2024
Last update
Jul 4, 2025

Study contacts

Zev Schuman-Olivier, MD
principal investigator · Cambridge Health Alliance

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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