Activation of the Endocannabinoid System and Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

blinding

Study Groups

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Dronabinol PTSD

Donabinol before cognitve testing - PTSD patients

Group Type ACTIVE_COMPARATOR

Dronabinol 2.5 mg

Intervention Type DRUG

single administration of 2.5mg Dronabinol oral (oily solution)

Dronabinol healthy controls

Donabinol before cognitve testing - healthy controls

Group Type ACTIVE_COMPARATOR

Dronabinol 2.5 mg

Intervention Type DRUG

single administration of 2.5mg Dronabinol oral (oily solution)

Placebo PTSD

Placebo before cognitve testing - PTSD patients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single administration of placebo oral (oily solution)

Placebo healthy controls

Placebo before cognitve testing - healthy controls

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single administration of placebo oral (oily solution)

Interventions

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Dronabinol 2.5 mg

single administration of 2.5mg Dronabinol oral (oily solution)

Intervention Type DRUG

Placebo

single administration of placebo oral (oily solution)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes