Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427568
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 28, 2015
Results First Submitted Date  ICMJE May 25, 2021
Results First Posted Date  ICMJE August 2, 2021
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2021)
  • Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive.
  • Baseline STAI Trait Score [ Time Frame: 3 months post-enrollment ]
    The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.
  • Primary Endpoint STAI Trait Score [ Time Frame: One month post-2nd experimental session ]
    The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Change in State Trait Anxiety Inventory (STAI) Trait Score - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Measure of trait anxiety from self-report measure of anxiety
  • Change in STAi score Trait score - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Measure of trait anxiety from self-report measure of anxiety
  • Change in STAI score Trait (12 month follow up) [ Time Frame: Baseline - up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Measure of trait anxiety from self-report measure of anxiety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2021)
  • Change in STAI State Score From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The state subscale of the STAI (STAI-S) is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Like the trait subscale, participants respond to each item on the state subscale by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.
  • Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Beck Depression Inventory-II (BDI-II) is a a 21-item self-reported measure of depression according to Diagnostic and Statistical Manual IV (DSM-IV) criteria. Each item is rated on a 4-point Likert scale ranging from 0 to 3. The total score is the sum of 21 items and range from 0 to 63. Score cutoffs indicate: 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression. Higher scores indicate more severe depressive symptoms.
  • Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session) ]
    The Global Assessment of Function (GAF) is a measure of a person's global social functioning made through clinical observation. The GAF consists of a single score, with scores ranging from 0 to 100, with 100 reflecting superior function and zero reflecting serious risk of causing harm to the self or others.
  • Change in MADRS Score From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item, clinician administered questionnaire used to diagnose the severity of depressive episodes. Each item has a score of 0 to 6. Overall scores are summed and range from 0 to 60. Score cutoffs indicate: 0-6 normal/symptom absent, 7-19 mild depression, 20-34 moderate depression, > 34 severe depression. Higher scores indicate greater severe depression.
  • Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Pittsburgh Sleep Quality Index (PSQI) is a measure of self-reported sleep quality over a one month period. It consists of 19 items with possible responses ranging from zero to four on a five-point scale. The PSQI consists of seven sub-scales: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. These are all summed to produce a single global scale. Global scores can range from 0 to 21, with higher scores reflecting poorer sleep quality, and a score below 5 indicating good sleep quality.
  • Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.
  • Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) is a 27-item self-report measure of quality of life issues specifically relevant to individuals with a chronic or life-threatening illness or condition. The core questionnaire consists of four subscales: Physical Well-being, Social/Family Well-being, Emotional Well-being, and Functional Well-being. Responses range from 0 (not at all) to 4 (very much), with higher scores indicating greater well-being. For each subscale, total scores were summed and range from 0 to 16.
  • Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Death Attitudes Profile (DAP) is a 32-item self-reported questionnaire that assesses individual attitudes and beliefs about death and dying. Each item on the scale is rated along a 7-point Likert scale ranging from "strongly disagree" (score of 1) to "strongly agree" (score of 7), with higher scores indicating more positive attitudes toward death. The DAP consists of 5 dimensions: fear of death (7 items summed with total scores ranging from 7 to 49), death avoidance (5 items summed with total scores ranging from 5 to 35), neutral acceptance (5 items summed with total scores ranging from 5 to 35), approach acceptance (10 items summed with total scores ranging from 10 to 70), and escape acceptance (5 items summed with total scores ranging from 5 to 35). For each dimension, a mean scale score can be computed by dividing the total scale score by the number of items forming each scale.
  • Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint [ Time Frame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session) ]
    The Self-Compassion Scale (SCS) is a 26-item self-reported questionnaire that assesses how respondents relate to themselves and treat themselves during difficult or painful experiences. Items are scored along a 5-point Likert-type scale ranging from 1 "almost never" to 5 "almost always." The SCS has six component (subscale) scores: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale scores are calculated by computing the mean of subscale item responses. A total self-compassion score is calculated by the sum of the subscale scores and range from 24 to 120 with higher scores indicating greater self compassion. Higher scores have been found to correlate with positive mental health outcomes, as well as decreased depression and anxiety.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Change in State Trait Anxiety Inventory (STAI) State score - Primary endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Measure of state anxiety from self-report measure of anxiety
  • Change in State Trait Anxiety Inventory (STAI) State score - 6 month follow up [ Time Frame: Baseline - up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Measure of state anxiety from self-report measure of anxiety
  • Change in State Trait Anxiety Inventory (STAI) State score - 12 month follow up [ Time Frame: Baseline - up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Measure of state anxiety from self-report measure of anxiety
  • Change in Beck Depression Inventory II score - 3rd Integration session [ Time Frame: Baseline - 1.5 months from enrollment ]
    Self-report measure of depression symptoms
  • Change in Beck Depression Inventory II score - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report measure of depression symptoms
  • Change in Beck Depression Inventory II score - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of depression symptoms
  • Change in Beck Depression Inventory II score - 12 month follow up [ Time Frame: Baseline - Up to18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of depression symptoms
  • Change in Global Assessment of Functioning (GAF) score - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
  • Change in Global Assessment of Functioning (GAF) score - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
  • Change in Global Assessment of Functioning (GAF) score - 12 month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
  • Columbia Suicide Severity Rating Scale (CSSRS) Baseline [ Time Frame: Baseline (screening / enrollment) ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • Average Pre-treatment CSSRS [ Time Frame: Average of CSSRS scores collected from 1 week post enrollment to up to 3 weeks post-enrollment ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • Average CSSRS - Experimental sessions [ Time Frame: (Average) of CSSRS scores collected from all experimental sessions 1 month from enrollment and 2 months from enrollment, with at least two scores recorded during each session ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • Average Post-treatment CSSRS [ Time Frame: Average scores from 1 month+1 day from enrollment to 3 months from enrollment ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • 6 month Follow up CSSRS [ Time Frame: Up to 11 months post day of drug administration 2 (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • 12 month Follow up CSSRS [ Time Frame: Up to 18 months post day of drug administration 2 (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Interviewer-administered measure of suicidal thinking (ideation) and behavior
  • Change in MADRS score - Primary endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Montgomery Asberg Depression Scale; short interview measuring depression
  • Change in MADRS score - Six-month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Montgomery Asberg Depression Scale; short interview measuring depression
  • Change in MADRS score - 12-month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Montgomery Asberg Depression Scale; short interview measuring depression
  • Pittsburgh Sleep Quality Inventory (PSQI) - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report measure of sleep quality
  • Pittsburgh Sleep Quality Inventory (PSQI) - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of sleep quality
  • Pittsburgh Sleep Quality Inventory (PSQI) - 12 month follow up [ Time Frame: Baseline - Up to 18 months post day of drug administrastion 2 (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of sleep quality
  • Change in Posttraumatic Growth Inventory (PTGI) - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report measure of post-traumatic growth
  • Change in Posttraumatic Growth Inventory (PTGI) - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of post-traumatic growth
  • Change in Posttraumatic Growth Inventory (PTGI) - 12 month follow up [ Time Frame: Baseline - Up to 18 months post day of drug administration 2 (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of post-traumatic growth
  • Posttraumatic Growth Inventory, Caregiver form - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Modified version of the PTGI completed by selected caregiver
  • Posttraumatic Growth Inventory, Caregiver form - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Modified version of the PTGI completed by selected caregiver
  • Posttraumatic Growth Inventory, Caregiver form - 12 month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Modified version of the PTGI completed by selected caregiver
  • Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report measure of quality of life designed for people with life-threatening illnesses
  • Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) - 6 month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of quality of life designed for people with life-threatening illnesses
  • Functional Assessment of Chronic Illness Therapy Scale (FACIT-Sp) - 12 month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (16 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of quality of life designed for people with life-threatening illnesses
  • Change in Death Attitude Profile (DAP) - Primary Endpoint [ Time Frame: Baseline -3 months from enrollment ]
    Self-report measure of attitudes concerning death
  • Change in Death Attitude Profile (DAP) - 6 Month Follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of attitudes concerning death
  • Change in Death Attitude Profile (DAP) - 12 Month Follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of attitudes concerning death
  • Change in Five-Factor Mindfulness Questionnaire (FFMQ) - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report questionnaire on mindfulness
  • Change in Five-Factor Mindfulness Questionnaire (FFMQ) - 6 Month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report questionnaire on mindfulness
  • Change in Five-Factor Mindfulness Questionnaire (FFMQ) - 12 Month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report questionnaire on mindfulness
  • Change in Self-Compassion Scale (SCS) - Primary Endpoint [ Time Frame: Baseline - 3 months from enrollment ]
    Self-report measure of self-compassion
  • Change in Self-Compassion Scale (SCS) - 6 Month follow up [ Time Frame: Baseline - Up to 11 months from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of self-compassion
  • Change in Self-Compassion Scale (SCS) - 12 Month follow up [ Time Frame: Baseline - Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Self-report measure of self-compassion
  • Long Term Follow Up Questionnaire - 6 Month follow up [ Time Frame: 9 or 11 months from enrollment (dependent upon enrollment in stage 2) ]
  • Long Term Follow Up Questionnaire - 12 Month follow up [ Time Frame: 15 or 18 months from enrollment (depending upon enrollment in stage 2) ]
  • Observer Rating Form scores - Baseline [ Time Frame: Baseline ]
    Measure of participant mood, demeanor and behavior completed by up to 3 individuals selected by the participant
  • Observer Rating Form scores - Primary Endpoint [ Time Frame: 3 months from enrollment ]
    Measure of participant mood, demeanor and behavior completed by up to 3 individuals selected by the participant
  • Observer Rating Form scores - 6 Month follow up [ Time Frame: Up to 11 months day from enrollment (9 or 11 months dependent upon subject enrolled in stage 2) ]
    Measure of participant mood, demeanor and behavior completed by up to 3 individuals selected by the participant
  • Observer Rating Form scores - 12 Month follow up [ Time Frame: Up to 18 months from enrollment (15 or 18 months dependent upon subject enrolled in stage 2) ]
    Measure of participant mood, demeanor and behavior completed by up to 3 individuals selected by the participant
  • Brief Pain Inventory - Short Version (BPI-S) - Baseline [ Time Frame: Baseline value ]
    Self-report measure of pain symptoms
  • Average Brief Pain Inventory - Short Version (BPI-S) Score after drug [ Time Frame: 1 and 2 months from enrollment (averaged) ]
    Self-report measure of pain symptoms
  • Brief Pain Inventory - Short Version (BPI-S) Score - Primary Endpoint [ Time Frame: 3 months from enrollment ]
    Self-report measure of pain symptoms
  • Average pre-drug Systolic Blood Pressure (SBP) [ Time Frame: Averaged pre-drug SBP across readings on two separate drug administration days 1 month and 2 months from enrollment ]
    Single SBP value prior to drug administration, for comparison with maximum and final readings
  • Average peak Systolic Blood Pressure (SBP) [ Time Frame: Average peak SBP across two separate druga dministration days 1 month and 2 months from enrollment ]
    Highest SBP value recorded during 8 hours of experimental session
  • Average end of Session Systolic Blood Pressure (SBP) [ Time Frame: Average end of session SBP across two separate drug administration days 1 month and 2 months from enrollment ]
    Last SBP value recorded for experimental session
  • Average pre-drug diastolic blood pressure (DBP) [ Time Frame: Averaged pre-drug DBP across two separate drug administration days 1 month and 2 months from enrollment ]
    Single DBP value prior to drug administration, for comparison with peak and end of session readings.
  • Average peak diastolic blood pressure (DBP) [ Time Frame: Average peak DBP across two separate drug administration days 1 month and 2 months from enrollment ]
    Highest DBP value recorded during 8 hours of experimental session
  • Average end of session diastolic blood pressure (DBP) [ Time Frame: Average end of session DBP across two separate drug administration days 1 month and 2 months from enrollment ]
    Last DBP value recorded for experimental session
  • Average pre-drug heart rate (HR) [ Time Frame: Averaged pre-drug HR across two separate drug administration days 1 month and 2 months from enrollment ]
    Single HR value prior to drug administration, for comparison with peak and end of session readings.
  • Average peak heart rate (HR) [ Time Frame: Average peak HR across two separate drug administration days 1 month and 2 months from enrollment ]
    Highest heart rate value recorded during 8-hour experimental session
  • Average end of session heart rate (HR) [ Time Frame: Averaged end of session HR across two separate drug administration days 1 month and 2 months from enrollment ]
    Last heart rate value recorded for experimental session
  • Average pre-drug body temperature [ Time Frame: Averaged pre-drug body temperature (BT) across two separate drug administration days 1 month and 2 months from enrollment ]
    Single BT value prior to drug administration, for comparison with peak and end of session readings.
  • Average peak body temperature [ Time Frame: Average peak BT across two separate drug administration days 1 month and 2 months from enrollment ]
    Highest body temperature value recorded during 8-hour experimental session
  • Average end of session body temperature [ Time Frame: Average end of session BT across two separate drug administration days 1 month and 2 months from enrollment ]
    Last body temperature reading for experimental session
  • Average pre-drug Subjective Units of Distress (SUD) [ Time Frame: Averaged pre-drug SUD across drug administration 1, drug administration 2 ]
    Single SUD rating level of distress on 1-7 scale
  • Average peak Subjective Units of Distress (SUD) [ Time Frame: Average peak SUD across two separate drug administration days 1 month and 2 months from enrollment ]
    Highest rating level of distress on 1-7 scale during each 8-hour experimental session
  • Average end of session Subjective Units of Distress (SUD) [ Time Frame: Average end of session SUD across two separate drug administration days 1 month and 2 months from enrollment ]
    Last rating level of distress on 1-7 scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Brief Summary This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study will consist of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA. Only subjects who receive active dose MDMA will complete an optional third open-label experimental session.
Detailed Description

Individuals facing, or who have faced, a life-threatening illness contend with more than just the physical symptoms of their condition and may experience anxiety, depression, anger, and despair that can exacerbate their distress. Research suggests that diagnosis of, and living with a life-threatening illness can result in symptoms similar to those seen in posttraumatic stress disorder (PTSD).

3,-4-methylenedioxymethamphetamine (MDMA) is a monoamine releaser with a unique pharmacological profile that include decreased feelings of fear, increased positive mood and increased interpersonal trust. Findings from clinical trials in people with PTSD and anecdotal reports suggest that MDMA-assisted psychotherapy may assist people who have anxiety related to having a life-threatening illness.

This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study will consist of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving MDMA will complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA-assisted therapy in 3 sessions.

The primary objective of the study is to assess changes in trait anxiety in subjects receiving active dose MDMA compared to those receiving placebo as measured by State-Trait Anxiety Index (STAI) Trait scores from Baseline to the Primary Endpoint (one month after the second experimental session).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Drug: MDMA (125 mg)
    Two sessions of MDMA (with therapy) lasting six to eight hours, scheduled two to four weeks apart.
    Other Name: 3,4-methylenedioxymethamphetamine
  • Drug: Placebo
    Two sessions of placebo (with therapy) lasting six to eight hours, scheduled two to four weeks apart.
    Other Name: Inactive placebo
  • Behavioral: Therapy
    Non-directive therapy
Study Arms  ICMJE
  • Placebo Comparator: Placebo with therapy
    Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose.
    Interventions:
    • Drug: Placebo
    • Behavioral: Therapy
  • Active Comparator: MDMA-assisted therapy (125 mg)
    125 mg 3,4-methylenedioxymethamphetamine (MDMA) administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg MDMA.
    Interventions:
    • Drug: MDMA (125 mg)
    • Behavioral: Therapy
Publications * Wolfson PE, Andries J, Feduccia AA, Jerome L, Wang JB, Williams E, Carlin SC, Sola E, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020 Nov 24;10(1):20442. doi: 10.1038/s41598-020-75706-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with life-threatening cancer or non-dementing neurological illness, which can be ongoing or in remission, but with a possibility of recurrence
  • Prognosis of at least nine months life expectancy from the time of screening
  • Have anxiety as a result of facing their illness
  • Are at least 18 years old
  • Are willing to refrain from taking any psychiatric medications during the study period;
  • Are willing to commit to medication dosing, experimental sessions, follow-up sessions, and to complete evaluation instruments
  • Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
  • Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
  • Are willing to select up to three observers who will complete observer measures of subject attitudes and behavior
  • Negative pregnancy test if able to bear children and agree to use effective birth control
  • Are proficient in speaking and reading English
  • Agree to have all psychotherapy sessions recorded to audio/video.

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 48 kg
  • Are abusing illegal drugs
  • Are unable to give adequate informed consent
  • Upon review of past, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427568
Other Study ID Numbers  ICMJE MDA-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will share outcome data appearing in any published reports upon request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data and study-related documents will be available when all participants have completed the study, and when data has been quality checked and locked.
Access Criteria: Interested persons should correspond with the central contact for the multisite study.
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Wolfson, MD Private Practice
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP