Clinical trial NCT06076564: Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose Mortality
Official title: Leveraging Psychological Autopsies to Accelerate Research Into Stimulant Overdose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stimulant Overdose
Overdose Accidental
Overdose Cocaine
Overdose Methamphetamine
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
First posted: 2023-10-11
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical antecedents to stimulant overdose.
timeFrame: One year prior to the date of death.
measure: Antecedent patterns between stimulant overdose deaths with and without fentanyl.
timeFrame: One year prior to the date of death.
measure: Resilience factors and risk reduction strategies among living persons who use stimulants.
timeFrame: One year prior to the interview date.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Department of Public Health
state: California
Study officials:
References: