Denmark

Medical Only (Private)

Reimbursed Care Access

Denmark currently permits regulated medical use of esketamine (Spravato) within the health system with hospital-based delivery and no automatic outpatient pharmacy subsidy; ketamine is used off‑label in specialist and research settings. Classic psychedelics (psilocybin, MDMA) are accessible only via approved clinical trials or research projects; classical entheogens and many tryptamines/phenethylamines (DMT, 5‑MeO‑DMT, ibogaine, mescaline, 2C‑X) remain controlled or functionally illegal for recreational/medical use outside research, though plant decoctions like ayahuasca occupy a legal gray area because plant material is not always separately scheduled even when constituent DMT is banned.

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Clinical Trials in Denmark

Active not recruitingPhase I

LSD Occupancy of the Serotonin 2A Receptor in the Human Brain (dOccLS)

Early‑Phase interventional dose-ranging study (n=40) assessing LSD single doses (25–200 µg) to quantify 5‑HT2A receptor occupancy in healthy participants using [11C]CIMBI‑36 PET/MR.

Started: November 8, 2023
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT05953038

RecruitingPhase IV

The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury

This randomised, blinded, placebo-controlled, parallel-group pilot and feasibility trial (n=400) will investigate the efficacy and safety of using esketamine for the treatment of patients with severe acute brain injury. It will specifically focus on cortical spreading depolarisations (SDs) in TBI, aSAH, or ICH.

Started: September 15, 2023
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT05095857

Active not recruitingPhase III

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (COMP 006)

Phase III, randomised, double-blind, parallel-group study (n=568) comparing two administrations of COMP360 psilocybin at 25 mg, 10 mg and 1 mg in adults with treatment-resistant depression.

Started: February 1, 2023
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT05711940

Unknown statusPhase II

Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Randomised, double-blind, placebo-controlled Phase II trial (n=90) testing a single 25 mg dose of psilocybin plus psychological support versus placebo in treatment-seeking adults (20–70 yrs) with alcohol use disorder.

Started: October 10, 2022
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT05416229

Active not recruitingPhase II

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Open-label, single-group Phase II feasibility study (n=10) administering a single oral dose of psilocybin 25 mg to people with alcohol use disorder to assess safety, feasibility and psilocin pharmacokinetics.

Started: January 20, 2021
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT04718792

Active not recruitingPhase II

Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial

This randomized, double-blinded, placebo-controlled trial (n=100) tests whether a single 25 mg oral psilocybin capsule reduces heavy drinking days in patients with alcohol use disorder.

Started: December 16, 2020
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: 2020-000829-55

Denmark

Reimbursed Care Access

Clinical Trials in Denmark

LSD Occupancy of the Serotonin 2A Receptor in the Human Brain (dOccLS)

The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (COMP 006)

Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial

Research Events

Organizations3

Aarhus University

Palner Lab

University of Copenhagen

Company

Product

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