LSD (Lysergic acid diethylamide) - Treatment in patients with cluster headaches

Switzerland (ICTRP)

ID di studio ICTRP
NCT03781128 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Safety and efficacy of lysergic acid diethylamide (LSD) as treatment for cluster headache: a randomized, double-blind, placebo-controlled phase II study (BASEC)

Titolo accademico
Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study (ICTRP)

Titolo pubblico
Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache (ICTRP)

Malattie studiate
Cluster Headache (ICTRP)

Intervento studiato
Drug: Lysergic Acid DiethylamideDrug: Placebo (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- 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

- Sufficient understanding of the study procedures and risks associated with the study

- Participants must be willing to adhere to the study procedures and sign the consent
form

- Participants are willing to abstain from taking preventive and abortive medication
(except from oxygen) long enough before and after the LSD/placebo treatment session
to avoid the possibility of a drug-drug interaction

- Participants are willing to refrain from taking any psychiatric medications during
the experimental session period. If they are being treated with antidepressants,
lithium or are taking anxiolytic medications on a fixed daily regimen, such drugs
must be discontinued long enough before the LSD/placebo treatment session to avoid
the possibility of a drug-drug interaction.

- Participants must also refrain from the use of any psychoactive drugs and caffeine
within 24 hours of each LSD/placebo treatment session. They must agree not to use
nicotine for at least 2 hours before and 6 hours after each dose of LSD. They must
agree to not ingest alcohol-containing beverages for at least 1 day before each LSD
treatment session. Non-routine medications for treating breakthrough pain taken in
the 24 hours before the LSD treatment session may result in rescheduling the
treatment session to another date, with the decision at the discretion of the
investigators after discussion with the participant.

- Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 hours after LSD/placebo administration.

Exclusion Criteria:

- 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).

- Current substance use disorder (within the last 2 months, DSM-V, except nicotine).

- Somatic disorders including severe cardiovascular disease, untreated hypertension
(systolic blood pressure > 160mmHg without treatment, systolic blood pressure > 140
mmHg with treatment), severe liver disease (liver enzymes increase by more than 5
times the upper limit of normal) or severely impaired renal function (estimated
creatinine clearance <30 ml/min), or other that in the judgement of the
investigators pose too great potential for side effects.

- Weight < 45kg

- Participation in another clinical trial (currently or within the last 30 days)

- Participants taking higher steroid doses (>10mg/d) over a longer time period (>2
weeks), as this would require tapering

- Use of immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

- Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks (ICTRP)

non disponibile

Endpoint primari e secondari
Change in frequency of the cluster headache attacks;Change in intensity of the cluster headache attacks (ICTRP)

Episode abortion;Change in duration of attacks;Time to first attack after completion of pulse regimen;Cumulative time with headache;Change in cluster period duration and interval between cluster periods;Number of attacks requiring abortive medication;Number of Attack-associated autonomic symptoms;Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36);Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L);Quality of life assessed by questionnaires: Headache Impact Test (HIT-6);Effects on depressive /anxious symptoms assessed by questionnaires: State-trait anxiety inventory (STAI);Effects on depressive /anxious symptoms assessed by questionnaires: Generalized anxiety disorder-7 (GAD-7);Effects on depressive /anxious symptoms assessed by questionnaires: Hospital Anxiety and Depression Scale (HADS);Effects on depressive /anxious symptoms assessed by questionnaires: Beck Depression Inventory (BDI);Effects on depressive /anxious symptoms assessed by questionnaires: Patient health questionnaire-9 (PHQ-9);Acute autonomic effects assessed by blood pressure;Acute autonomic effects assessed by heart rate;Acute autonomic effects assessed by body temperature;Adverse Events;Acute psychological effects assessed by questionnaire Visual analogue scales (VAS);Acute psychological effects assessed by SCQ;Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness;Persisting effects attributed to the LSD experience;Change of attack frequency at the end of the study compared with baseline;Change of attack intensity at the end of the study compared with baseline;Change in attack frequency before and after pulse regimen;Change in attack intensity before and after pulse regimen;Blinding;Expectancy (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Matthias Liechti;Matthias Liechti, Prof.;Matthias Liechti, Prof., matthias.liechti@usb.ch, 0041 61 328 68 68;+41 61 328 68 68, University Hospital, Basel, Switzerland, (ICTRP)

ID secondari
BASEC 2018-01082 (ICTRP)

Risultati-Dati individuali dei partecipanti
No (ICTRP)

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03781128 (ICTRP)