Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality

NCT06076564 | Completed

• 1 other identifier: R01CE003364
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Stimulant Overdose; Overdose Accidental; Overdose Cocaine; Overdose Methamphetamine

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  One year prior to the interview date.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All informants must be at least 18 years of age and have knowledge of the decedent and that the decedent used substances.
• 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
• 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.

You may not qualify if:

• Informants:
• 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.

Sponsors & Collaborators

• San Francisco Department of Public Health: lead

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center on Substance Use and Health

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 11, 2023
• Study Start: June 6, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)