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Completed

NCT Number: NCT06076564

Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco Department of Public Health

San Francisco, California, 94102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

  • 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.

Exclusion:

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

San Francisco Department of Public Health

Other Gov

Registry information

Official study title

Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose

Acronym: LASSO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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