Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache

LSD

Brief Summary

Background: After no official research in humans in the last 40 years, research and therapeutic uses of the serotonergic psychedelic lysergic acid diethylamide (LSD) are now re-recognized and include its use in brain research, alcoholism, anxiety associated with terminal illness, and treatment of headache disorders. Specifically, LSD has been reported to abort attacks, to decrease frequency and intensity of attacks, and to induce remission in patients suffering from cluster headache (CH).

Objective: To investigate the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in patients suffering from CH compared with placebo.

Design: Double-blind, randomized, placebo-controlled two-phase cross-over study design.

Participants: 30 patients aged ≥ 25 and ≤ 75 years with chronic or episodic CH with predictable periods lasting approximately 2 months and attacks responding to oxygen.

Main outcome measures: Changes in frequency and intensity of CH attacks assessed with a standardized headache diary Significance: CH is often rated as the most painful of all primary headaches, which not only causes significant disability, but is also associated with enormous personal, economic, and psychiatric burden. At the moment, there is no specific treatment available for CH, but serotonergic compounds represent an important drug class, especially in the abortive management of cluster attacks. However, there is a need for new treatment approaches, as CH is also often insufficiently managed with available medication. This study will evaluate the potential benefit and safety of a treatment with LSD for patients with CH.

Intervention / Treatment

  • Drug: Lysergic Acid Diethylamide
  • Drug: Placebo

Condition or Disease

  • Cluster Headache

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 25 Years to 75 Years   (Adult, Older Adult)
Enrollment: 30 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 02, 2019
Primary Completion: Oct 23, 2022
Completion Date: Dec 23, 2022
Study First Posted: Dec 19, 2018
Results First Posted: Sep 25, 2020
Last Updated: Apr 20, 2021

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 25
Maximum Age: 75

This clinical trial is recruiting

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More Details

NCT Number: NCT03781128
Acronym: LCH
Other IDs: BASEC 2018-01082
Study URL: https://ClinicalTrials.gov/show/NCT03781128
Last updated: Mar 23, 2022