<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03781128</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2018-01082</org_study_id>
    <nct_id>NCT03781128</nct_id>
  </id_info>
  <brief_title>Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache</brief_title>
  <acronym>LCH</acronym>
  <official_title>Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: After no official research in humans in the last 40 years, research and&#xD;
      therapeutic uses of the serotonergic psychedelic lysergic acid diethylamide (LSD) are now&#xD;
      re-recognized and include its use in brain research, alcoholism, anxiety associated with&#xD;
      terminal illness, and treatment of headache disorders. Specifically, LSD has been reported to&#xD;
      abort attacks, to decrease frequency and intensity of attacks, and to induce remission in&#xD;
      patients suffering from cluster headache (CH).&#xD;
&#xD;
      Objective: To investigate the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three&#xD;
      weeks) in patients suffering from CH compared with placebo.&#xD;
&#xD;
      Design: Double-blind, randomized, placebo-controlled two-phase cross-over study design.&#xD;
&#xD;
      Participants: 30 patients aged ≥ 25 and ≤ 75 years with chronic or episodic CH with&#xD;
      predictable periods lasting approximately 2 months and attacks responding to oxygen.&#xD;
&#xD;
      Main outcome measures: Changes in frequency and intensity of CH attacks assessed with a&#xD;
      standardized headache diary Significance: CH is often rated as the most painful of all&#xD;
      primary headaches, which not only causes significant disability, but is also associated with&#xD;
      enormous personal, economic, and psychiatric burden. At the moment, there is no specific&#xD;
      treatment available for CH, but serotonergic compounds represent an important drug class,&#xD;
      especially in the abortive management of cluster attacks. However, there is a need for new&#xD;
      treatment approaches, as CH is also often insufficiently managed with available medication.&#xD;
      This study will evaluate the potential benefit and safety of a treatment with LSD for&#xD;
      patients with CH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Double-blind, randomized, placebo-controlled two-phase cross-over study design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in frequency of the cluster headache attacks</measure>
    <time_frame>8 weeks before and after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary, within-subjects analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in intensity of the cluster headache attacks</measure>
    <time_frame>8 weeks before and after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary, within-subjects analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Episode abortion</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in duration of attacks</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first attack after completion of pulse regimen</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative time with headache</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cluster period duration and interval between cluster periods</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attacks requiring abortive medication</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Attack-associated autonomic symptoms</measure>
    <time_frame>8 weeks after pulse regimen</time_frame>
    <description>assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the validated 36-item short-form health survey (SF-36), which measures health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the 5-level EuroQoL-5D (EQ-5D-5L), which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by questionnaires: Headache Impact Test (HIT-6)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the Headache Impact Test (HIT-6), which measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on depressive /anxious symptoms assessed by questionnaires: State-trait anxiety inventory (STAI)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the State-trait anxiety inventory (STAI), which measures anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on depressive /anxious symptoms assessed by questionnaires: Generalized anxiety disorder-7 (GAD-7)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the Generalized anxiety disorder (GAD-7), which measures anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on depressive /anxious symptoms assessed by questionnaires: Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on depressive /anxious symptoms assessed by questionnaires: Beck Depression Inventory (BDI)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the Beck Depression Inventory (BDI), which measures depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on depressive /anxious symptoms assessed by questionnaires: Patient health questionnaire-9 (PHQ-9)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment with the Patient health questionnaire-9 (PHQ-9), which measures depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute autonomic effects assessed by blood pressure</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>systolic and diastolic blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute autonomic effects assessed by heart rate</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute autonomic effects assessed by body temperature</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>body temperature in °Celsius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>adverse events will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute psychological effects assessed by questionnaire Visual analogue scales (VAS)</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>assessment of subjective effects using visual analogue scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute psychological effects assessed by SCQ</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>assessed with the states of consciousness questionnaire (SCQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness</measure>
    <time_frame>10 hours after drug administration</time_frame>
    <description>assessed with the 5-dimensions of altered states of consciousness questionnaire (5D-ASC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persisting effects attributed to the LSD experience</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>assessment of persisting effects with the persisting effects questionnaire (PEQ) which assesses changes in attitude, mood, behavior and spiritual experience. The questionnaire will be completed at the beginning, after pulse regimens, and at the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of attack frequency at the end of the study compared with baseline</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>pre-post study comparison in all subjects, assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of attack intensity at the end of the study compared with baseline</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>pre-post study comparison in all subjects, assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attack frequency before and after pulse regimen</measure>
    <time_frame>8 weeks after first pulse regimen</time_frame>
    <description>between-subjects analysis before cross-over, assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attack intensity before and after pulse regimen</measure>
    <time_frame>8 weeks after first pulse regimen</time_frame>
    <description>between-subjects analysis before cross-over, assessed with a standardized headache diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinding</measure>
    <time_frame>after study days and at the end of study visit</time_frame>
    <description>patients and investigators will be asked at the end of a study day and and the end of the study visit to guess the drug treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expectancy</measure>
    <time_frame>at screening</time_frame>
    <description>a modified 2-item version of the Credibility / Expectancy Questionnaire (CEQ) will be used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cluster Headache</condition>
  <arm_group>
    <arm_group_label>LSD, Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lysergic acid diethylamide (3 x 100 µg LSD in three weeks, per os) followed by Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, LSD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placebo (3 x 1 vial looking like LSD in three weeks, per os) followed by Lysergic acid diethylamide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lysergic Acid Diethylamide</intervention_name>
    <description>100 µg, per os, 3 times within 3 weeks</description>
    <arm_group_label>LSD, Placebo</arm_group_label>
    <arm_group_label>Placebo, LSD</arm_group_label>
    <other_name>LSD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks</description>
    <arm_group_label>LSD, Placebo</arm_group_label>
    <arm_group_label>Placebo, LSD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 25 and ≤ 75 years&#xD;
&#xD;
          -  Chronic cluster headache (according to the International Headache Society (IHS)&#xD;
             criteria) OR&#xD;
&#xD;
          -  Episodic cluster headache (according to the IHS criteria) with recurrent predictable&#xD;
             episodes lasting approximately 2 months and expected ongoing cluster period for at&#xD;
             least one month beyond the inclusion&#xD;
&#xD;
          -  Attacks respond to oxygen&#xD;
&#xD;
          -  Sufficient understanding of the study procedures and risks associated with the study&#xD;
&#xD;
          -  Participants must be willing to adhere to the study procedures and sign the consent&#xD;
             form&#xD;
&#xD;
          -  Participants are willing to abstain from taking preventive and abortive medication&#xD;
             (except from oxygen) long enough before and after the LSD/placebo treatment session to&#xD;
             avoid the possibility of a drug-drug interaction&#xD;
&#xD;
          -  Participants are willing to refrain from taking any psychiatric medications during the&#xD;
             experimental session period. If they are being treated with antidepressants, lithium&#xD;
             or are taking anxiolytic medications on a fixed daily regimen, such drugs must be&#xD;
             discontinued long enough before the LSD/placebo treatment session to avoid the&#xD;
             possibility of a drug-drug interaction.&#xD;
&#xD;
          -  Participants must also refrain from the use of any psychoactive drugs and caffeine&#xD;
             within 24 hours of each LSD/placebo treatment session. They must agree not to use&#xD;
             nicotine for at least 2 hours before and 6 hours after each dose of LSD. They must&#xD;
             agree to not ingest alcohol-containing beverages for at least 1 day before each LSD&#xD;
             treatment session. Non-routine medications for treating breakthrough pain taken in the&#xD;
             24 hours before the LSD treatment session may result in rescheduling the treatment&#xD;
             session to another date, with the decision at the discretion of the investigators&#xD;
             after discussion with the participant.&#xD;
&#xD;
          -  Participants must be willing not to drive a traffic vehicle or to operate machines&#xD;
             within 24 hours after LSD/placebo administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other forms of headache attacks (migraine, paroxysmal hemicranias, shortlasting&#xD;
             unilateral neuralgiform headache attacks with conjunctival injection, tearing,&#xD;
             sweating and rhinorrhea (SUNCT) or with cranial autonomic symptoms (SUNA))&#xD;
&#xD;
          -  Women who are pregnant, nursing or of child-bearing potential and are not practicing&#xD;
             an effective means of birth control (double-barrier method, i.e. pill/intrauterine&#xD;
             device and preservative/diaphragm)&#xD;
&#xD;
          -  Past or present diagnosis of a primary psychotic disorder. Subjects with a first&#xD;
             degree relative with psychotic disorders are also excluded.&#xD;
&#xD;
          -  Past or present bipolar disorder (DSM-IV).&#xD;
&#xD;
          -  Current substance use disorder (within the last 2 months, DSM-V, except nicotine).&#xD;
&#xD;
          -  Somatic disorders including severe cardiovascular disease, untreated hypertension&#xD;
             (systolic blood pressure &gt; 160mmHg without treatment, systolic blood pressure &gt; 140&#xD;
             mmHg with treatment), severe liver disease (liver enzymes increase by more than 5&#xD;
             times the upper limit of normal) or severely impaired renal function (estimated&#xD;
             creatinine clearance &lt;30 ml/min), or other that in the judgement of the investigators&#xD;
             pose too great potential for side effects.&#xD;
&#xD;
          -  Weight &lt; 45kg&#xD;
&#xD;
          -  Participation in another clinical trial (currently or within the last 30 days)&#xD;
&#xD;
          -  Participants taking higher steroid doses (&gt;10mg/d) over a longer time period (&gt;2&#xD;
             weeks), as this would require tapering&#xD;
&#xD;
          -  Use of immunomodulatory agents (i.e. azathioprine) in the past 2 weeks&#xD;
&#xD;
          -  Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Liechti</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthias Liechti, Prof.</last_name>
    <phone>0041 61 328 68 68</phone>
    <email>matthias.liechti@usb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yasmin Schmid, Dr. med.</last_name>
    <phone>0041 61 328 68 66</phone>
    <email>yasmin.schmid@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Pharmacology &amp; Toxicology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Liechti, Prof.</last_name>
      <phone>+41 61 328 68 68</phone>
      <email>matthias.liechti@usb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Yasmin Schmid, Dr. med.</last_name>
      <phone>+41 61 328 68 66</phone>
      <email>yasmin.schmid@usb.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Matthias Liechti, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lysergic acid diethylamide (LSD)</keyword>
  <keyword>serotonin</keyword>
  <keyword>hallucinogen</keyword>
  <keyword>cluster headache</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cluster Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lysergic Acid Diethylamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781128
org study id: BASEC 2018-01082
nct id: NCT03781128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Double-blind, randomized, placebo-controlled two-phase cross-over study design.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double-blind
measure: Change in frequency of the cluster headache attacks
time frame: 8 weeks before and after pulse regimen
description: assessed with a standardized headache diary, within-subjects analysis
measure: Change in intensity of the cluster headache attacks
time frame: 8 weeks before and after pulse regimen
description: assessed with a standardized headache diary, within-subjects analysis
measure: Episode abortion
time frame: through study completion, an average of 1 year
description: assessed with a standardized headache diary
measure: Change in duration of attacks
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Time to first attack after completion of pulse regimen
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Cumulative time with headache
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Change in cluster period duration and interval between cluster periods
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Number of attacks requiring abortive medication
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Number of Attack-associated autonomic symptoms
time frame: 8 weeks after pulse regimen
description: assessed with a standardized headache diary
measure: Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36)
time frame: through study completion, an average of 1 year
description: assessment with the validated 36-item short-form health survey (SF-36), which measures health-related quality of life
measure: Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L)
time frame: through study completion, an average of 1 year
description: assessment with the 5-level EuroQoL-5D (EQ-5D-5L), which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life
measure: Quality of life assessed by questionnaires: Headache Impact Test (HIT-6)
time frame: through study completion, an average of 1 year
description: assessment with the Headache Impact Test (HIT-6), which measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress.
measure: Effects on depressive /anxious symptoms assessed by questionnaires: State-trait anxiety inventory (STAI)
time frame: through study completion, an average of 1 year
description: assessment with the State-trait anxiety inventory (STAI), which measures anxiety
measure: Effects on depressive /anxious symptoms assessed by questionnaires: Generalized anxiety disorder-7 (GAD-7)
time frame: through study completion, an average of 1 year
description: assessment with the Generalized anxiety disorder (GAD-7), which measures anxiety
measure: Effects on depressive /anxious symptoms assessed by questionnaires: Hospital Anxiety and Depression Scale (HADS)
time frame: through study completion, an average of 1 year
description: assessment with the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression severity
measure: Effects on depressive /anxious symptoms assessed by questionnaires: Beck Depression Inventory (BDI)
time frame: through study completion, an average of 1 year
description: assessment with the Beck Depression Inventory (BDI), which measures depression
measure: Effects on depressive /anxious symptoms assessed by questionnaires: Patient health questionnaire-9 (PHQ-9)
time frame: through study completion, an average of 1 year
description: assessment with the Patient health questionnaire-9 (PHQ-9), which measures depression
measure: Acute autonomic effects assessed by blood pressure
time frame: 10 hours after drug administration
description: systolic and diastolic blood pressure in mmHg
measure: Acute autonomic effects assessed by heart rate
time frame: 10 hours after drug administration
description: heart rate in beats per minute
measure: Acute autonomic effects assessed by body temperature
time frame: 10 hours after drug administration
description: body temperature in °Celsius
measure: Adverse Events
time frame: through study completion, an average of 1 year
description: adverse events will be recorded
measure: Acute psychological effects assessed by questionnaire Visual analogue scales (VAS)
time frame: 10 hours after drug administration
description: assessment of subjective effects using visual analogue scales
measure: Acute psychological effects assessed by SCQ
time frame: 10 hours after drug administration
description: assessed with the states of consciousness questionnaire (SCQ)
measure: Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness
time frame: 10 hours after drug administration
description: assessed with the 5-dimensions of altered states of consciousness questionnaire (5D-ASC)
measure: Persisting effects attributed to the LSD experience
time frame: through study completion, an average of 1 year
description: assessment of persisting effects with the persisting effects questionnaire (PEQ) which assesses changes in attitude, mood, behavior and spiritual experience. The questionnaire will be completed at the beginning, after pulse regimens, and at the end of the study.
measure: Change of attack frequency at the end of the study compared with baseline
time frame: through study completion, an average of 1 year
description: pre-post study comparison in all subjects, assessed with a standardized headache diary
measure: Change of attack intensity at the end of the study compared with baseline
time frame: through study completion, an average of 1 year
description: pre-post study comparison in all subjects, assessed with a standardized headache diary
measure: Change in attack frequency before and after pulse regimen
time frame: 8 weeks after first pulse regimen
description: between-subjects analysis before cross-over, assessed with a standardized headache diary
measure: Change in attack intensity before and after pulse regimen
time frame: 8 weeks after first pulse regimen
description: between-subjects analysis before cross-over, assessed with a standardized headache diary
measure: Blinding
time frame: after study days and at the end of study visit
description: patients and investigators will be asked at the end of a study day and and the end of the study visit to guess the drug treatment
measure: Expectancy
time frame: at screening
description: a modified 2-item version of the Credibility / Expectancy Questionnaire (CEQ) will be used
arm group label: LSD, Placebo
arm group type: Other
description: Lysergic acid diethylamide (3 x 100 µg LSD in three weeks, per os) followed by Placebo
arm group label: Placebo, LSD
arm group type: Other
description: Placebo (3 x 1 vial looking like LSD in three weeks, per os) followed by Lysergic acid diethylamide
intervention type: Drug
intervention name: Lysergic Acid Diethylamide
description: 100 µg, per os, 3 times within 3 weeks
arm group label: LSD, Placebo
arm group label: Placebo, LSD
other name: LSD
intervention type: Drug
intervention name: Placebo
description: placebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks
arm group label: LSD, Placebo
arm group label: Placebo, LSD
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Matthias Liechti
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Matthias Liechti, Prof.
phone: 0041 61 328 68 68
email: matthias.liechti@usb.ch
last name: Yasmin Schmid, Dr. med.
phone: 0041 61 328 68 66
email: yasmin.schmid@usb.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Headache
mesh term: Lysergic Acid Diethylamide
sharing ipd: No