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NCT Number: NCT04871269

The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Steglitz, State of Berlin, 10249, Germany

About this study

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).

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 (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy female volunteers
  • German on a native level

Exclusion criteria

  • former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
  • any physical illnesses
  • any medication intake (except oral contraceptive)
  • history of traumatic experience, e.g. history of sexual abuse or rape
  • pregnancy or lactation period
  • follicular phase of menstrual cycle for all women not using oral contraceptives

Treatment and study plan

Dronabinol

Drug

Dronabinol

Placebo

Drug

Placebo

Primary outcomes

  1. Change of Intrusive Memories in the following four days after the intervention

    Time frame: four consecutive days

    Influence of dronabinol on the development of intrusive memories measured with an intrusion diary

Secondary outcomes

  1. Noradrenergic System (measured with salivary alpha-amylase - u/ml)

    Time frame: Day 1

    Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase

  2. Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)

    Time frame: Time Frame: Day 1

    Influence of dronabinol on the HPA-axis measured with salivary cortisol

  3. Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories

    Time frame: Day 1

    Influence of polygenic risk score on development of intrusive memories

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
May 4, 2021
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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