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

NCT ID: NCT04871269

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2025-08-28

Brief Summary

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.

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.

Conditions

Intrusive Memories

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Drug: Dronabinol before the trauma film paradigm

Group Type: EXPERIMENTAL

Dronabinol

Intervention Type: DRUG

Dronabinol

Placebo

Intervention Type: DRUG

Placebo

Drug: Dronabinol after the trauma film paradigm

Group Type: EXPERIMENTAL

Dronabinol

Intervention Type: DRUG

Dronabinol

Placebo

Intervention Type: DRUG

Placebo

Placebo before and after the trauma film paradigm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Dronabinol

Dronabinol

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan Roepke

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Röpke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Katja Wingenfeld, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Steglitz, State of Berlin, Germany

Countries

Germany

Other Identifiers

DroMemo

Identifier Type: -

Identifier Source: org_study_id