Activation of the Endocannabinoid System and Cognition (DronaMemo-2)

Charité University Medicine Berlin

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Dronabinol 2.5 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05226351

WI 3396/14-1 // RO 3935/7-1

Details and patient eligibility

About

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

Full description

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). 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, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.

Enrollment: 192 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PTSD criteria fullfilled (patients only)

Exclusion criteria

• All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded.
• Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded.
• psychiatric disorder according to DSM-5 (healthy controls only)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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192 participants in 4 patient groups, including a placebo group

Dronabinol PTSD

Active Comparator group

Description:

Donabinol before cognitve testing - PTSD patients

Treatment:

Drug: Dronabinol 2.5 mg

Dronabinol healthy controls

Active Comparator group

Description:

Donabinol before cognitve testing - healthy controls

Treatment:

Drug: Dronabinol 2.5 mg

Placebo PTSD

Placebo Comparator group

Description:

Placebo before cognitve testing - PTSD patients

Treatment:

Drug: Placebo

Placebo healthy controls

Placebo Comparator group

Description:

Placebo before cognitve testing - healthy controls

Treatment:

Drug: Placebo