MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

Sponsor
Multidisciplinary Association for Psychedelic Studies (Other)
Overall Status
Completed
CT.gov ID
NCT00090064
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
78
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. It is most likely to occur following an event involving perceived personal threat, such as rape or physical assault. PTSD is clearly a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs.

MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted psychotherapy may benefit people with PTSD.

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of preparatory sessions and several non-drug therapy sessions to facilitate integration of material arising during experimental sessions.

During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second MDMA or placebo session in Stage 1 and four to six weeks after the second MDMA session in Stage 2. A final data-collection session took place at two months after the third experimental session.

The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving the placebo vs. full dose of MDMA-assisted psychotherapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: MDMA-assisted therapy

Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions.

Drug: 3,4-methylenedioxymethamphetamine
125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA
Other Names:
  • MDMA
  • Behavioral: Therapy
    Non-directive therapy provided by a team of two co-therapists

    Placebo Comparator: Placebo with therapy

    Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.

    Drug: Lactose placebo pill
    125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo
    Other Names:
  • Placebo
  • Behavioral: Therapy
    Non-directive therapy provided by a team of two co-therapists

    Outcome Measures

    Primary Outcome Measures

    1. Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [Less than 4 weeks before first experimental session]

      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.

    2. Primary Endpoint Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [2 months after second experimental session]

      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.

    3. Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up [Baseline to 2 months post second experimental session]

      The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

    Secondary Outcome Measures

    1. Baseline Impact of Events Scale Revised (IES-R) [Baseline (less than 4 weeks before first experimental session)]

      The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

    2. Primary Endpoint Impact of Events Scale Revised (IES-R) [2 months after second experimental session]

      The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

    3. Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up [Baseline to 2 months post second experimental session]

      The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Be diagnosed with chronic PTSD, duration of 5 years or longer resulting from traumatic experience during military service or a victim of crime;

    • Have a CAPS score showing moderate to severe PTSD symptoms;

    1. Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.

    2. Are at least 18 years old;

    • Must be generally healthy;

    • Must sign a medical release for the investigators to communicate directly with their therapist and doctors;

    • Are willing to refrain from taking any psychiatric medications during the study period;

    • Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;

    • Willing to remain overnight at the study site;

    • Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;

    • are willing to be contacted via telephone for all necessary telephone contacts;

    • Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;

    • must provide a contact in the event of a participant becoming suicidal;

    • Are proficient in speaking and reading English;

    • agree to have all clinic visit sessions recorded to audio and video

    • Agree not to participate in any other interventional clinical trials during the duration of this study.

    Exclusion Criteria:
    • Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;

    • Weigh less than 50 kg;

    • Are abusing illegal drugs;

    • Are unable to give adequate informed consent;

    • Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary.

    • Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Offices of Michael Mithoefer MDMount PleasantSouth CarolinaUnited States29464

    Sponsors and Collaborators

    • Multidisciplinary Association for Psychedelic Studies

    Investigators

    • Principal Investigator: Michael Mithoefer, MD, Private Practice

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Multidisciplinary Association for Psychedelic Studies
    ClinicalTrials.gov Identifier:
    NCT00090064
    Other Study ID Numbers:
    • MP1
    First Posted:
    Aug 25, 2004
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Multidisciplinary Association for Psychedelic Studies
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsParticipants were recruited via letters to psychotherapists and internet advertisements.
    Pre-assignment Detail
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Period Title: Overall Study
    STARTED158
    COMPLETED128
    NOT COMPLETED30

    Baseline Characteristics

    Arm/Group TitleMDMA-assisted TherapyPlacebo With TherapyTotal
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.Total of all reporting groups
    Overall Participants12820
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    40.2
    (7.6)
    40.8
    (7.0)
    40.4
    (7.2)
    Sex: Female, Male (Count of Participants)
    Female
    10
    83.3%
    7
    87.5%
    17
    85%
    Male
    2
    16.7%
    1
    12.5%
    3
    15%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    12
    100%
    8
    100%
    20
    100%
    On disability for PTSD (Count of Participants)
    Count of Participants [Participants]
    2
    16.7%
    1
    12.5%
    3
    15%
    History of alcohol abuse/dependency (Count of Participants)
    Count of Participants [Participants]
    1
    8.3%
    1
    12.5%
    2
    10%
    History of other substance abuse/dependency (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    1
    12.5%
    1
    5%
    Duration of PTSD (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    232
    (201)
    273
    (126)
    248
    (173)
    Comorbid major depression (Count of Participants)
    Count of Participants [Participants]
    9
    75%
    7
    87.5%
    16
    80%
    Comorbid anxiety disorder (Count of Participants)
    Count of Participants [Participants]
    2
    16.7%
    1
    12.5%
    3
    15%
    Prior therapy duration (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    40.6
    (38.5)
    85.3
    (54.2)
    58.5
    (49.5)

    Outcome Measures

    1. Primary Outcome
    TitleBaseline 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    80.5
    (21.73)
    79.6
    (21.97)
    2. Primary Outcome
    TitlePrimary Endpoint 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 Frame2 months after second experimental session

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    25.3
    (25.02)
    59.1
    (28.90)
    3. Primary Outcome
    TitleChange in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up
    DescriptionThe Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
    Time FrameBaseline to 2 months post second experimental session

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions. 3,4-methylenedioxymethamphetamine: 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA Therapy: Non-directive therapy provided by a team of two co-therapistsParticipants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions. Lactose placebo pill: 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo Therapy: Non-directive therapy provided by a team of two co-therapists
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    -55.2
    (33.54)
    -20.5
    (20.47)
    4. Secondary Outcome
    TitleBaseline Impact of Events Scale Revised (IES-R)
    DescriptionThe Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
    Time FrameBaseline (less than 4 weeks before first experimental session)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    44.9
    (16.77)
    45.1
    (11.84)
    5. Secondary Outcome
    TitlePrimary Endpoint Impact of Events Scale Revised (IES-R)
    DescriptionThe Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
    Time Frame2 months after second experimental session

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    15.0
    (15.82)
    26.5
    (16.28)
    6. Secondary Outcome
    TitleChange in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up
    DescriptionThe Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
    Time FrameBaseline to 2 months post second experimental session

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleMDMA-assisted TherapyPlacebo With Therapy
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
    Measure Participants128
    Mean (Standard Deviation) [score on a scale]
    -29.9
    (22.23)
    -14.7
    (15.58)

    Adverse Events

    Time FrameFrom baseline to the end of Stage 2 (approximately 8 months)
    Adverse Event Reporting Description
    Arm/Group TitleMDMA-assisted Therapy (Stage 1)Placebo With Therapy (Stage 1)MDMA-assisted Therapy (Stage 2)
    Arm/Group DescriptionParticipants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
    All Cause Mortality
    MDMA-assisted Therapy (Stage 1)Placebo With Therapy (Stage 1)MDMA-assisted Therapy (Stage 2)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/15 (0%) 0/8 (0%) 0/7 (0%)
    Serious Adverse Events
    MDMA-assisted Therapy (Stage 1)Placebo With Therapy (Stage 1)MDMA-assisted Therapy (Stage 2)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/15 (13.3%) 0/8 (0%) 0/7 (0%)
    Musculoskeletal and connective tissue disorders
    Clavicle fracture1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Nervous system disorders
    Syncope1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Other (Not Including Serious) Adverse Events
    MDMA-assisted Therapy (Stage 1)Placebo With Therapy (Stage 1)MDMA-assisted Therapy (Stage 2)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total14/15 (93.3%) 6/8 (75%) 6/7 (85.7%)
    Cardiac disorders
    Sinus tachycardia1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Palpitations0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    Eye disorders
    Vision blurred1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Visual impairment2/15 (13.3%) 1/8 (12.5%) 0/7 (0%)
    Gastrointestinal disorders
    Diarrhea3/15 (20%) 41/8 (12.5%) 42/7 (28.6%) 4
    Dyspepsia1/15 (6.7%) 0/8 (0%) 1/7 (14.3%)
    Nausea1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Oropharyngeal blistering1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Vomiting1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Abdominal pain upper0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Gastric ulcer0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    General disorders
    Asthenia1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Chills1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Fatigue4/15 (26.7%) 61/8 (12.5%) 31/7 (14.3%) 3
    Feeling hot2/15 (13.3%) 0/8 (0%) 0/7 (0%)
    Influenza like illness1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Irritability2/15 (13.3%) 0/8 (0%) 0/7 (0%)
    Pain1/15 (6.7%) 1/8 (12.5%) 2/7 (28.6%)
    Facial pain0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Infections and infestations
    Laryngitis1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Pharyngitis streptococcal1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Sinusitis1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Upper respiratory tract infection2/15 (13.3%) 1/8 (12.5%) 2/7 (28.6%)
    Urinary tract infection1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Otitis media0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Pharyngitis0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Metabolism and nutrition disorders
    Anorexia1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain1/15 (6.7%) 1/8 (12.5%) 0/7 (0%)
    Muscle spasms1/15 (6.7%) 1/8 (12.5%) 0/7 (0%)
    Muscle strain1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Muscle tightness5/15 (33.3%) 1/8 (12.5%) 21/7 (14.3%) 2
    Musculoskeletal pain2/15 (13.3%) 1/8 (12.5%) 1/7 (14.3%)
    Neck pain1/15 (6.7%) 1/8 (12.5%) 0/7 (0%)
    Musculoskeletal chest pain0/15 (0%) 2/8 (25%) 40/7 (0%) 4
    Pain in extremity0/15 (0%) 1/8 (12.5%) 21/7 (14.3%) 2
    Arthralgia0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Myalgia0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    Nervous system disorders
    Burning sensation1/15 (6.7%) 1/8 (12.5%) 21/7 (14.3%) 2
    Dizziness1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Headache1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Hypoaesthesia facial1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Myoclonus1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Tension headache1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Sciatica0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Psychiatric disorders
    Anxiety2/15 (13.3%) 4/8 (50%) 63/7 (42.9%) 6
    Bruxism1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Depressed mood1/15 (6.7%) 1/8 (12.5%) 20/7 (0%) 2
    Derealisation1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Dissociation1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Disturbance in attention1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Major depression1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Panic attack1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Insomnia0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Memory impairment0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Agitation0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    Flashback0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    Renal and urinary disorders
    Dysuria1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Nocturia1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Reproductive system and breast disorders
    Ovarian cyst1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Sinus headache1/15 (6.7%) 0/8 (0%) 0/7 (0%)
    Throat tightness0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus0/15 (0%) 1/8 (12.5%) 0/7 (0%)
    Dermatitis0/15 (0%) 0/8 (0%) 1/7 (14.3%)
    Surgical and medical procedures
    Foot operation1/15 (6.7%) 0/8 (0%) 0/7 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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:
    NCT00090064
    Other Study ID Numbers:
    • MP1
    First Posted:
    Aug 25, 2004
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021