Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

Sponsor
Multidisciplinary Association for Psychedelic Studies (Other)
Overall Status
Completed
CT.gov ID
NCT00353938
Collaborator
Swiss Medical Association for Psycholytic Therapy (Other)
14
Enrollment
1
Location
2
Arms
52
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: 3,4-methylenedioxymethamphetamine (125 mg)
  • Drug: 3,4-methyelendioxymethamphetamine (25 mg)
  • Behavioral: Therapy
Phase 2

Detailed Description

Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering.

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

ArmIntervention/Treatment
Experimental: Full Dose MDMA-assisted therapy (125 mg)

Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA

Drug: 3,4-methylenedioxymethamphetamine (125 mg)
Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.
Other Names:
  • MDMA
  • Behavioral: Therapy
    Non-directive therapy performed by a team of two co-therapists

    Active Comparator: Active Placebo MDMA-assisted therapy (25 mg)

    Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA

    Drug: 3,4-methyelendioxymethamphetamine (25 mg)
    Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.
    Other Names:
  • MDMA
  • Behavioral: Therapy
    Non-directive therapy performed by a team of two co-therapists

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) [Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)]

      The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

    Secondary Outcome Measures

    1. Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS) [Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)]

      The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with posttraumatic stress disorder (PTSD).

    • PTSD still remains after one or more prior treatment, with treatment including psychotherapy (talk therapy) or drug therapy

    • May meet criteria for a mood disorder

    • Must be at least 18 years old

    • Must be able to stop taking psychiatric medication during the course of the study, from the start of the study to the follow-up two months after experimental session 3.

    • Must agree to follow all rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption.

    • Must be willing to stay overnight at the researcher's office after each experimental session until the non-drug session occurring the next morning.

    • Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.

    • Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control.

    • Participants must have sufficient proficiency in speaking the German language to participate in MDMA-assisted psychotherapy. Participants must be able to read documents in German.

    Exclusion Criteria:
    • Cannot have history of or current primary psychotic disorder or bipolar affective disorder-1.

    • Dissociative identity disorder, or an eating disorder with active purging or borderline personality disorder.

    • Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).

    • Uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.

    • Being pregnant or lactating (nursing), or not practicing an effective method of birth control.

    • Weight of less than 50 or more than 105 kg.

    • Patients reporting prior use of "Ecstasy" more than 5 times or at any time within the previous 6 months.

    • People who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.

    • People who need ongoing concomitant therapy with a psychotropic drug.

    • Meeting DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.

    • People who cannot give adequate consent.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Offices of Peter Oehen MDBiberistSolothurnSwitzerland

    Sponsors and Collaborators

    • Multidisciplinary Association for Psychedelic Studies
    • Swiss Medical Association for Psycholytic Therapy

    Investigators

    • Principal Investigator: Peter Oehen, MD, private practice, Biberist, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Multidisciplinary Association for Psychedelic Studies
    ClinicalTrials.gov Identifier:
    NCT00353938
    Other Study ID Numbers:
    • M-P2
    First Posted:
    Jul 19, 2006
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Multidisciplinary Association for Psychedelic Studies
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsParticipants were recruited by calling for referrals from psychiatric hospitals, trauma counseling centers, psychiatrists and psychotherapists in the German-speaking part of Switzerland.
    Pre-assignment DetailOnly active control participants from Stage 1 entered into open-label Stage 2 and only participants who received full dose in Stage1 or Stage 2 and did not respond with significant improvement were offered the opportunity to partake in open-label Stage 3.
    Arm/Group TitleFull Dose MDMA-assisted Therapy (125 mg Stage 1)Active Placebo MDMA-assisted Therapy (25 mg Stage 1)Full Dose MDMA-assisted Therapy (125 mg Stage 2)Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
    Arm/Group DescriptionThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
    Period Title: Stage 1
    STARTED9500
    COMPLETED8500
    NOT COMPLETED1000
    Period Title: Stage 1
    STARTED0040
    COMPLETED0040
    NOT COMPLETED0000
    Period Title: Stage 1
    STARTED0003
    COMPLETED0003
    NOT COMPLETED0000

    Baseline Characteristics

    Arm/Group TitleFull Dose MDMA-assisted Therapy (125 mg)Active Placebo MDMA-assisted Therapy (25 mg)Total
    Arm/Group DescriptionThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsTotal of all reporting groups
    Overall Participants8412
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.1
    (12.8)
    40.0
    (6.2)
    41.4
    (11.2)
    Sex: Female, Male (Count of Participants)
    Female
    7
    87.5%
    3
    75%
    10
    83.3%
    Male
    1
    12.5%
    1
    25%
    2
    16.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Country of origin (Count of Participants)
    Switzerland
    7
    87.5%
    4
    100%
    11
    91.7%
    France
    1
    12.5%
    0
    0%
    1
    8.3%
    Work status (Count of Participants)
    On disability
    4
    50%
    1
    25%
    5
    41.7%
    Fit for limited employment
    2
    25%
    1
    25%
    3
    25%
    Working full-time
    1
    12.5%
    2
    50%
    3
    25%
    Retired
    1
    12.5%
    0
    0%
    1
    8.3%
    Duration of PTSD (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    16.4
    (10.9)
    22.3
    (12.1)
    18.3
    (12.0)
    Duration of prior therapy (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    39.9
    (73.3)
    123
    (60.6)
    85.8
    (71.4)
    On medication for PTSD at enrollment (Count of Participants)
    Yes
    4
    50%
    2
    50%
    6
    50%
    No
    4
    50%
    2
    50%
    6
    50%

    Outcome Measures

    1. Primary Outcome
    TitleChange From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
    DescriptionThe CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
    Time FrameLess than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFull Dose MDMA-assisted Therapy (125 mg)Active Placebo MDMA-assisted Therapy (25 mg)
    Arm/Group DescriptionThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists
    Measure Participants84
    Mean (Standard Deviation) [score on a scale]
    -15.6
    (18.1)
    -3.2
    (15.3)
    2. Secondary Outcome
    TitleChange From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
    DescriptionThe Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.
    Time FrameLess than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleFull Dose MDMA-assisted Therapy (125 mg)Active Placebo MDMA-assisted Therapy (25 mg)
    Arm/Group DescriptionThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists
    Measure Participants84
    Mean (Standard Deviation) [score on a scale]
    -8.6
    (13.0)
    7.3
    (6.2)

    Adverse Events

    Time FrameFrom baseline to end of Stage 3 (approximately 1 year)
    Adverse Event Reporting Description
    Arm/Group TitleFull Dose MDMA-assisted Therapy (125 mg Stage 1)Active Placebo MDMA-assisted Therapy (25 mg Stage 1)Full Dose MDMA-assisted Therapy (125 mg Stage 2)Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
    Arm/Group DescriptionThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapistsThree 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
    All Cause Mortality
    Full Dose MDMA-assisted Therapy (125 mg Stage 1)Active Placebo MDMA-assisted Therapy (25 mg Stage 1)Full Dose MDMA-assisted Therapy (125 mg Stage 2)Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Serious Adverse Events
    Full Dose MDMA-assisted Therapy (125 mg Stage 1)Active Placebo MDMA-assisted Therapy (25 mg Stage 1)Full Dose MDMA-assisted Therapy (125 mg Stage 2)Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/9 (22.2%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metasteses to central nervous system1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Psychiatric disorders
    Suicidal behavior1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Other (Not Including Serious) Adverse Events
    Full Dose MDMA-assisted Therapy (125 mg Stage 1)Active Placebo MDMA-assisted Therapy (25 mg Stage 1)Full Dose MDMA-assisted Therapy (125 mg Stage 2)Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total8/9 (88.9%) 3/5 (60%) 2/4 (50%) 1/3 (33.3%)
    Ear and labyrinth disorders
    Otitis media0/9 (0%) 1/5 (20%) 0/4 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Abdominal Pain1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Diarrhea1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Nausea1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Vomiting1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Abdominal pain lower1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    General disorders
    Fatigue1/9 (11.1%) 2/5 (40%) 1/4 (25%) 1/3 (33.3%)
    Pain0/9 (0%) 1/5 (20%) 0/4 (0%) 0/3 (0%)
    Infections and infestations
    Urinary tract infection0/9 (0%) 0/5 (0%) 1/4 (25%) 0/3 (0%)
    Angina tonsillitus0/9 (0%) 0/5 (0%) 0/4 (0%) 1/3 (33.3%)
    Injury, poisoning and procedural complications
    Limb injury1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Investigations
    Red blood cell sedimentation rate increased1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Metabolism and nutrition disorders
    Decreased appetite1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Hypothyroidism1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Iron deficiency Anemia0/9 (0%) 0/5 (0%) 1/4 (25%) 0/3 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle spasms0/9 (0%) 0/5 (0%) 1/4 (25%) 0/3 (0%)
    Neck pain0/9 (0%) 0/5 (0%) 1/4 (25%) 0/3 (0%)
    Nervous system disorders
    Dizziness1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Headache1/9 (11.1%) 1/5 (20%) 1/4 (25%) 0/3 (0%)
    Visual acuity reduced1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Psychiatric disorders
    Panic attack1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Anxiety4/9 (44.4%) 1/5 (20%) 0/4 (0%) 0/3 (0%)
    Depressed mood2/9 (22.2%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Disturbance in attention2/9 (22.2%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Insomnia2/9 (22.2%) 1/5 (20%) 1/4 (25%) 0/3 (0%)
    Somatoform disorder1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Somnolence1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Tension1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Intentional self-injury0/9 (0%) 1/5 (20%) 0/4 (0%) 0/3 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Pneumonia1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Pneumonia chlamydial1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Bronchial disorder0/9 (0%) 1/5 (20%) 0/4 (0%) 0/3 (0%)
    Skin and subcutaneous tissue disorders
    Psoriasis1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)
    Vascular disorders
    Hypertension1/9 (11.1%) 0/5 (0%) 0/4 (0%) 0/3 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleJulie B. Wang, MPH, PhD/ Senior Clinical Data Scientist
    OrganizationMultidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.
    Phone(831) 429-6362
    Emailjuliewang@mapsbcorp.com
    Responsible Party:
    Multidisciplinary Association for Psychedelic Studies
    ClinicalTrials.gov Identifier:
    NCT00353938
    Other Study ID Numbers:
    • M-P2
    First Posted:
    Jul 19, 2006
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022