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Clinical trial

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

ID
Name
DroMemo
Description
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.
Trial arms
Trial start
2021-05-01
Estimated PCD
2023-12-31
Trial end
2024-08-28
Status
Recruiting
Treatment
Dronabinol
Dronabinol
Arms:
Drug: Dronabinol after the trauma film paradigm, Drug: Dronabinol before the trauma film paradigm
Placebo
Placebo
Arms:
Drug: Dronabinol after the trauma film paradigm, Drug: Dronabinol before the trauma film paradigm, Placebo before and after the trauma film paradigm
Size
291
Primary endpoint
Change of Intrusive Memories in the following four days after the intervention
four consecutive days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 291, 'type': 'ESTIMATED'}}
Updated at
2024-02-13

1 organization

2 products

1 indication

Organization
Charite University
Product
Dronabinol
Indication
Post-Traumatic Stress Disorder
Product
Placebo