LASSO: Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality

Sponsor
San Francisco Department of Public Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT06076564
Collaborator
(none)
260
1
27.8
9.4

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    260 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose
    Actual Study Start Date :
    Jun 6, 2022
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Sep 29, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical antecedents to stimulant overdose. [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.

    2. Antecedent patterns between stimulant overdose deaths with and without fentanyl. [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.

    3. Resilience factors and risk reduction strategies among living persons who use stimulants. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion:

    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

    1. are aware the decedent used substances in the past year prior the to date of death AND

    2. 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

    1. are aware the decedent used substances in the past 30 days prior to the date of death and

    2. have been in contact with the decedent in person in the past year prior to the date of death.

    Living persons who use stimulants:
    1. ≥18 years of age,

    2. Used cocaine or methamphetamine for ≥5 years,

    3. Used cocaine or methamphetamine for ≥10 out of the past 30 days, AND

    4. Matched to a decedent on age, race/ethnicity, gender, and neighborhood distribution of decedents of the methamphetamine/no opioid and cocaine/no opioid decedents.

    Exclusion:
    Informants:

    No exclusion criteria.

    Living persons who use stimulants:
    1. Used both cocaine and methamphetamine ≥5 of past 30 days,

    2. Intentionally use illicit opioids, OR

    3. Unable to communicate in English or Spanish.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco Department of Public Health San Francisco California United States 94102

    Sponsors and Collaborators

    • San Francisco Department of Public Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Phillip Coffin, MD, MIA, Director, Center on Substance Use and Health, San Francisco Department of Public Health
    ClinicalTrials.gov Identifier:
    NCT06076564
    Other Study ID Numbers:
    • R01CE003364
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2023