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Completed

NCT Number: NCT05226351

Activation of the Endocannabinoid System and Cognition

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Dronabinol 2.5 MG

Drug

single administration of 2.5mg Dronabinol oral (oily solution)

Placebo

Drug

single administration of placebo oral (oily solution)

Primary outcomes

  1. extinction learning

    Time frame: 30 minutes

    extinction learning in fear conditioning paradigm: skin conductance reaction

Secondary outcomes

  1. empathy

    Time frame: 15 minutes

    cognitive and emotional empathy: number of correct answers & rating of own emotional state

  2. Probabilistic Reversal Learning Task

    Time frame: 15 minutes

    learning and cognitive flexibility: reaction times

  3. selective attention

    Time frame: 10 minutes

    emotional dot-probe task: attentional bias index

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: DronaMemo-2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2022
Registry last updated
Mar 10, 2025

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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