Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
ConditionCluster Headache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 25 and ≤ 75 years
Chronic cluster headache (according to the International Headache Society (IHS) criteria) OR
Episodic cluster headache (according to the IHS criteria) with recurrent predictable episodes lasting approximately 2 months and expected ongoing cluster period for at least one month beyond the inclusion
Attacks respond to oxygen
Disqualifiers
Other forms of headache attacks (migraine, paroxysmal hemicranias, shortlasting unilateral neuralgiform headache attacks with conjunctival injection, tearing, sweating and rhinorrhea (SUNCT) or with cranial autonomic symptoms (SUNA))
Women who are pregnant, nursing or of child-bearing potential and are not practicing an effective means of birth control (double-barrier method, i.e. pill/intrauterine device and preservative/diaphragm)
Past or present diagnosis of a primary psychotic disorder. Subjects with a first degree relative with psychotic disorders are also excluded.
Past or present bipolar disorder (DSM-IV).
Trial design
Design model
Crossover
Treatments tested in this trial
Lysergic Acid Diethylamide
Drug100 µg, per os, 3 times within 3 weeks
Placebo
Drugplacebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: LSD, PlaceboOther 2 interventions
Group B: Placebo, LSDOther 2 interventions
Trial outcomes
Primary outcomes
1
Change in frequency of the cluster headache attacks
assessed with a standardized headache diary, within-subjects analysis
Time frame
8 weeks before and after pulse regimen2
Change in intensity of the cluster headache attacks
assessed with a standardized headache diary, within-subjects analysis
Time frame
8 weeks before and after pulse regimenSecondary outcomes
1
Episode abortion
assessed with a standardized headache diary
Time frame
through study completion, an average of 1 year2
Change in duration of attacks
assessed with a standardized headache diary
Time frame
8 weeks after pulse regimen3
Time to first attack after completion of pulse regimen
assessed with a standardized headache diary
Time frame
8 weeks after pulse regimen4
Cumulative time with headache
assessed with a standardized headache diary
Time frame
8 weeks after pulse regimenSponsors and contacts
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Source ClinicalTrials.gov