Opioid Use DisorderNCT05116852
Community and Familial Impacts of the Opioid Crisis
An observational study of Opioid Use Disorder and Bereavement, run by Cambridge Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Bereavement, Overdose of Opiate
- What is being tested?
- Survey
- How many people
- 578 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to complete the survey
- Inability to speak, read, and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02141
About this study
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.
- Conditions
- Opioid Use Disorder, Bereavement, Overdose of Opiate
- Being tested
- Survey
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
This self-report aim will be assessed via participant survey response asking for recollection of mental health treatment before and after the loss.
Measured: 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.
This aim will be assessed via participant survey response between cohorts
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Apr 2022
- Primary completion21 Apr 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- The Sandra and Arnold Gold Humanism Research Fund
- Responsible party
- Principal investigator, Zev Schuman Olivier, Cambridge Health Alliance
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116852
- Sponsor's protocol ID
- CHA-IRB-20-21-7
- Status last verified
- Jul 2025
- First submitted
- 13 Oct 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Familial Impacts of the Opioid Crisis
- ClinicalTrials.gov ID
- NCT05116852
- Acronym / sponsor ID
- CHA-IRB-20-21-7
- Conditions
- Opioid Use Disorder, Bereavement, Overdose of Opiate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- The Sandra and Arnold Gold Humanism Research Fund
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Both grieving a loved one to opioid-related death and have an actively using loved one | – | Other: SurveyThese 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. |
| Individuals supporting a loved one in treatment for Opioid Use Disorder | – | Other: SurveyThese individuals will complete the study survey for their designated experience supporting a loved one in treatment for Opioid Use Disorder. |
| Individuals grieving a loved one to opioid-related death | – | Other: SurveyThese individuals will complete the study survey for their designated experience losing a loved one to opioid-related death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to complete the survey
- Inability to speak, read, and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAll 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. | Other | 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 |
Primary outcome
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.
Time frame: Day 1
This self-report aim will be assessed via participant survey response asking for recollection of substance use before and after the loss.
3 secondary outcomes
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.
Time frame: 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.
Time frame: Day 1
Prolonged Grief
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Bereavement, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.