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Activation of the Endocannabinoid System and Cognition

Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226351
Acronym
DronaMemo-2
Enrollment
192
Registered
2022-02-07
Start date
2022-03-01
Completion date
2024-08-15
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Brief summary

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

Detailed description

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.

Interventions

single administration of 2.5mg Dronabinol oral (oily solution)

DRUGPlacebo

single administration of placebo oral (oily solution)

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

blinding

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* PTSD criteria fullfilled (patients only)

Exclusion criteria

* All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded. * Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded. * psychiatric disorder according to DSM-5 (healthy controls only)

Design outcomes

Primary

MeasureTime frameDescription
extinction learning30 minutesextinction learning in fear conditioning paradigm: skin conductance reaction

Secondary

MeasureTime frameDescription
empathy15 minutescognitive and emotional empathy: number of correct answers & rating of own emotional state
Probabilistic Reversal Learning Task15 minuteslearning and cognitive flexibility: reaction times
selective attention10 minutesemotional dot-probe task: attentional bias index

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026