Autopsy report · NCT04596644

Impact of Repeatedly-Administered THC-cannabis on Experimental Pain and Abuse Liability in Humans

“In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months before it started.
• Suspended: paused, and may or may not restart.
• 16 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Phase

Phase 2

Sponsor

New York State Psychiatric Institute

Sponsor type

University, hospital or other

Conditions

Cannabis; Pain; Tolerance; Hyperalgesia

Interventions

Active Cannabis; Placebo Cannabis

Participants

16 (planned, not actual)

Sites

1

Countries

United States

Trials that died the same way

• Cognitive Remediation for Coordinated Specialty Care
  “U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.” (95% match in meaning)
• Scaffolding of Brain Operations
  “In response to quality assurance and compliance concerns about some specific studies, NYSPI is undertaking an Institute-wide safety review of human subjects research protocols. HHS OHRP issued an FWA restriction on NYSPI research as of 2023/6/23.” (85% match in meaning)
• Development of Novel Measures for Alzheimer's Disease Prevention Trials
  “The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of HHS Office of Human Research Protections (OHRP) issued a pause on human subjects research.” (67% match in meaning)
• Cognitive Functioning in Opioid Use Disorder
  “NYSPI-wide Institutional Research Pause as of June 12, 2023.” (60% match in meaning)
• Neuroinflammation in Patients With OCD
  “The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research on March 14, 2024.” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.