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

NCT04871269 | Active Not Recruiting

• 1 other identifier: DroMemo
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrusive Memories

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Day 1

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

  Time Frame: Day 1

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

  Day 1

Study Arms (3)

Drug: Dronabinol before the trauma film paradigm

EXPERIMENTAL

Drug: Dronabinol; Drug: Placebo

Drug: Dronabinol after the trauma film paradigm

EXPERIMENTAL

Drug: Dronabinol; Drug: Placebo

Placebo before and after the trauma film paradigm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dronabinol DRUG

Dronabinol

Drug: Dronabinol after the trauma film paradigm; Drug: Dronabinol before the trauma film paradigm

Placebo DRUG

Placebo

Drug: Dronabinol after the trauma film paradigm; Drug: Dronabinol before the trauma film paradigm; Placebo before and after the trauma film paradigm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy female volunteers
• German on a native level

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Steglitz, State of Berlin, 10249, Germany

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Stefan Röpke, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Katja Wingenfeld, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: August 28, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

DE (1)