Stimulant OverdoseLASSONCT06076564
Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality
An observational study of Stimulant Overdose and Overdose Accidental, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
In the LASSO study, the investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stimulant Overdose, Overdose Accidental, Overdose Cocaine
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 12 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All informants must be at least 18 years of age and have knowledge of the decedent and that the decedent used substances. Living persons who use stimulants must be at least 18 years of age and use cocaine or methamphetamine.
Who may be able to join
- All informants must be at least 18 years of age and have knowledge of the decedent and that the decedent used substances.
- If the contact has knowledge of the decedent's earlier life (e.g., family or long-term friend), the inclusion criteria are that they
- are aware the decedent used substances in the past year prior the to date of death AND
- have been in contact with the decedent in the past year prior to the date of death by phone, email, or in person
- OR
- If the contact has recent knowledge of the decedent (e.g., partners, friends, neighbors, or service providers), the inclusion criteria are that they
Show all 13Show fewer
- are aware the decedent used substances in the past 30 days prior to the date of death and
- have been in contact with the decedent in person in the past year prior to the date of death.
- Living persons who use stimulants:
- ≥18 years of age,
- Used cocaine or methamphetamine for ≥5 years,
- Used cocaine or methamphetamine for ≥10 out of the past 30 days, AND
- Matched to a decedent on age, race/ethnicity, gender, and neighborhood distribution of decedents of the methamphetamine/no opioid and cocaine/no opioid decedents.
Who cannot join
- Informants:
- No exclusion criteria.
- Living persons who use stimulants:
- Used both cocaine and methamphetamine ≥5 of past 30 days,
- Intentionally use illicit opioids, OR
- Unable to communicate in English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose
In the LASSO study, the investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case narrative, death scene photographs) and medical record abstraction. Subsequently, study staff will conduct qualitative interviews with 40-60 living people who use stimulants (aiming for half methamphetamine, half cocaine) to explore elements of resilience and risk reduction strategies. This study aims to contribute to the eventual design of interventions to reduce stimulant overdose mortality.
Read the detailed description
Death from acute stimulant toxicity ("overdose") is rapidly rising across the United States. While there are decades of research and program development undergirding opioid overdose prevention, there is minimal understanding of the nature of stimulant overdose mortality. Psychological autopsies have been shown to be immensely valuable in understanding opioid overdose deaths, identifying many of the key elements of overdose that still drive overdose prevention efforts today, and the investigators propose to leverage that mechanism to accelerate our understanding of and response to stimulant overdose mortality, as well as the role of fentanyl in fatal stimulant overdose.
The investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case narrative, death scene photographs) and medical record abstraction. Subsequently, the study team will conduct qualitative interviews with 40-60 living people who use stimulants (aiming for half methamphetamine, half cocaine) to explore elements of resilience and risk reduction strategies. This study aims to contribute to the eventual design of interventions to reduce stimulant overdose mortality.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Informants | Informants are individuals who knew someone who had a fatal stimulant overdose. Once a decedent is selected, their records will be reviewed to familiarize the interviewer with the situation of their death. Informants will be identified using contacts that the OCME used during their investigation, death records from the state, or emergency contacts from medical records, followed by recommendations from any of those contacts. | |
| Living Persons who use Stimulants | To identify resilience factors and risk reduction strategies among living persons who use stimulants, study staff will conduct interviews with up to 60 adults who use either cocaine or methamphetamine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical antecedents to stimulant overdose.
The investigators will use medical records and mortality data, as well as qualitative and quantitative interview data with close contacts, to identify medical, psychological, and substance use antecedents to stimulant overdose death.
Measured: One year prior to the date of death.
Antecedent patterns between stimulant overdose deaths with and without fentanyl.
The investigators will compare stimulant (without fentanyl) deaths to stimulant with fentanyl deaths to identify key differences, such as in substance use, suicidality, cardiac and other medical or psychiatric events, between the two groups.
Measured: One year prior to the date of death.
Resilience factors and risk reduction strategies among living persons who use stimulants.
The investigators will use quantitative and qualitative data obtained from interviews with people who use stimulants to identify resilience and risk reduction strategies that reduce the risk for fatal stimulant overdose.
Measured: One year prior to the interview date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start6 Jun 2022
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant OverdoseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076564
- Sponsor's protocol ID
- R01CE003364
- Acronym
- LASSO
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose
- ClinicalTrials.gov ID
- NCT06076564
- Acronym / sponsor ID
- LASSO / R01CE003364
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 11 Oct 2023 (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.
In the LASSO study, the investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case narrative, death scene photographs) and medical record abstraction. Subsequently, study staff will conduct qualitative interviews with 40-60 living people who use stimulants (aiming for half methamphetamine, half cocaine) to explore elements of resilience and risk reduction strategies. This study aims to contribute to the eventual design of interventions to reduce stimulant overdose mortality.
Detailed description
Death from acute stimulant toxicity ("overdose") is rapidly rising across the United States. While there are decades of research and program development undergirding opioid overdose prevention, there is minimal understanding of the nature of stimulant overdose mortality. Psychological autopsies have been shown to be immensely valuable in understanding opioid overdose deaths, identifying many of the key elements of overdose that still drive overdose prevention efforts today, and the investigators propose to leverage that mechanism to accelerate our understanding of and response to stimulant overdose mortality, as well as the role of fentanyl in fatal stimulant overdose.
The investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case narrative, death scene photographs) and medical record abstraction. Subsequently, the study team will conduct qualitative interviews with 40-60 living people who use stimulants (aiming for half methamphetamine, half cocaine) to explore elements of resilience and risk reduction strategies. This study aims to contribute to the eventual design of interventions to reduce stimulant overdose mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informants | – | –Informants are individuals who knew someone who had a fatal stimulant overdose. Once a decedent is selected, their records will be reviewed to familiarize the interviewer with the situation of their death. Informants will be identified using contacts that the OCME used during their investigation, death records from the state, or emergency contacts from medical records, followed by recommendations from any of those contacts. |
| Living Persons who use Stimulants | – | –To identify resilience factors and risk reduction strategies among living persons who use stimulants, study staff will conduct interviews with up to 60 adults who use either cocaine or methamphetamine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All informants must be at least 18 years of age and have knowledge of the decedent and that the decedent used substances. Living persons who use stimulants must be at least 18 years of age and use cocaine or methamphetamine.
Key inclusion criteria (13 listed)
- All informants must be at least 18 years of age and have knowledge of the decedent and that the decedent used substances.
- If the contact has knowledge of the decedent's earlier life (e.g., family or long-term friend), the inclusion criteria are that they
- are aware the decedent used substances in the past year prior the to date of death AND
- have been in contact with the decedent in the past year prior to the date of death by phone, email, or in person
- OR
Key exclusion criteria (6 listed)
- No exclusion criteria.
- Used both cocaine and methamphetamine ≥5 of past 30 days,
- Intentionally use illicit opioids, OR
- Unable to communicate in English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical antecedents to stimulant overdose.
Time frame: One year prior to the date of death.
The investigators will use medical records and mortality data, as well as qualitative and quantitative interview data with close contacts, to identify medical, psychological, and substance use antecedents to stimulant overdose death.
Antecedent patterns between stimulant overdose deaths with and without fentanyl.
Time frame: One year prior to the date of death.
The investigators will compare stimulant (without fentanyl) deaths to stimulant with fentanyl deaths to identify key differences, such as in substance use, suicidality, cardiac and other medical or psychiatric events, between the two groups.
Resilience factors and risk reduction strategies among living persons who use stimulants.
Time frame: One year prior to the interview date.
The investigators will use quantitative and qualitative data obtained from interviews with people who use stimulants to identify resilience and risk reduction strategies that reduce the risk for fatal stimulant overdose.
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 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stimulant Overdose and Overdose Accidental, run by San Francisco Department of Public Health 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 13 inclusion and 6 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 27 Nov 2024. 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?
Clinical antecedents to stimulant overdose. (time frame: One year prior to the date of death.). The study lists 3 primary outcomes in all. 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 27 Nov 2024.