Skip to content

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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04871269
Enrollment
291
Registered
2021-05-04
Start date
2021-05-01
Completion date
2025-08-28
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrusive Memories

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.

Interventions

DRUGDronabinol

Dronabinol

DRUGPlacebo

Placebo

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Intrusive Memories in the following four days after the interventionfour consecutive daysInfluence of dronabinol on the development of intrusive memories measured with an intrusion diary

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026