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.

Study Overview

• Status: Recruiting
• Conditions: Intrusive Memories
• Intervention / Treatment: Drug: Placebo; Drug: Dronabinol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 291
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tolou Maslahati, M.Sc.; Phone Number: 0049 030 450 517 567; Email: tolou.maslahati@charite.de

Study Locations

• Germany
  • Berlin
    • Berlin-Steglitz, Berlin, Germany, 10249
      • Recruiting
      • Charité - Universitätsmedizin Berlin
      • Contact: Tolou Maslahati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Dronabinol before the trauma film paradigm	Drug: Placebo; Placebo; Drug: Dronabinol; Dronabinol
Experimental: Drug: Dronabinol after the trauma film paradigm	Drug: Placebo; Placebo; Drug: Dronabinol; Dronabinol
Placebo Comparator: Placebo before and after the trauma film paradigm	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Intrusive Memories in the following four days after the intervention	Influence of dronabinol on the development of intrusive memories measured with an intrusion diary	four consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noradrenergic System (measured with salivary alpha-amylase - u/ml)	Influence of dronabinol on the noradrenergic system measured with salivary alpha-amylase	Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)	Influence of dronabinol on the HPA-axis measured with salivary cortisol	Time Frame: Day 1
Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories	Influence of polygenic risk score on development of intrusive memories	Day 1

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Stefan Röpke, Prof. Dr., Charite University, Berlin, Germany; Principal Investigator: Katja Wingenfeld, Prof. Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): August 28, 2024

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: DroMemo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No