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Correlates of Anxiety Associated With a Life-threatening Illness

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ClinicalTrials.gov Identifier: NCT02954562
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date November 2, 2016
First Posted Date November 3, 2016
Last Update Posted Date July 13, 2018
Actual Study Start Date November 7, 2015
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2016)
  • Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task [ Time Frame: Two months after enrollment in study NCT02427568) ]
    Changes in brain activity during passive observation versus attempts to reduce negative response to images
  • Changes in fMRI Blood Oxygen Level Dependent (BOLD) resting state functional connectivity [ Time Frame: Two months after enrollment in study NCT02427568) ]
    Changes in brain activity during resting state fMRI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 2, 2016)
  • Heart rate variability (HRV) during own versus other's anxiety script [ Time Frame: Two months after enrollment in study NCT02427568) ]
    Measuring changes in speed of heart rate while listening to a personalized versus a non-personalized anxiety script.
  • Changes in fMRI BOLD response during dot probe task [ Time Frame: Two months after enrollment in study NCT02427568) ]
    Assess response to images evoking positive or negative emotion
  • Response time to dot probe task [ Time Frame: Two months after enrollment in study MDA-1 ]
    Response time (RT) to viewing positive or negative valence images
  • Measure of compassion for self versus other [ Time Frame: Two months after enrollment in study NCT02427568) ]
    Compassion response listening to self-generated versus other-generated scripts
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlates of Anxiety Associated With a Life-threatening Illness
Official Title Physiological Correlates of Anxiety Associated With a Life-threatening Illness.
Brief Summary In this study, people will be undergoing brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task that involves observing either neutral images or images known to induce negative emotions, with instructions either to view passively or attempt to reduce the negative affect associated with the images. Resting state brain scans (with no explicit task) will also be acquired. Heart rate variability will be measured during these resting state scans. While in the scanner, subjects will also listen to prerecorded audio scripts about life stresses for themselves and for another person with instructions to practice compassion for themselves or for others. In yet another task, they will respond to pictures known to produce positive and negative emotions and perform an attention related task. The scans will take place once before and at least once after undergoing sessions of methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain scans will happen three times: an initial scan before placebo or MDMA-assisted psychotherapy, a second scan after either two placebo or two MDMA sessions (depending on whether the subject was in the placebo or MDMA group), and one final scan after the conclusion of three active MDMA sessions.
Detailed Description

Diagnosis of, and living with a life-threatening illness can result in symptoms similar to those seen in Posttraumatic Stress Disorder (PTSD), and these symptoms may persist even if the individual recovers, or their illness goes into remission. These symptoms may include emotional avoidance and numbing, difficulty relating to or connecting with friends or loved ones, difficulty sleeping, a sense of foreshortened future, and intrusive thoughts or memories related to the illness. These symptoms are an additional burden for the individual experiencing them and for their caretakers, and reduces quality of life.

Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is an experimental treatment for anxiety disorders, and initial findings suggest that it holds promise for treatment of PTSD. This study will examine brain activity in participants enrolled in an investigation of the safety and efficacy of MDMA-assisted psychotherapy in people with anxiety stemming from diagnosis with a life-threatening illness to see whether MDMA-assisted psychotherapy alters emotional reactivity to anxiety-provoking material, including positive and negative images. The study will also examine brain activity related to the experience of self-compassion/empathy in response to personalized audio scripts, and whether that response is altered by MDMA-assisted psychotherapy. Brain imaging may offer a measure of neural markers of anxiety and self-compassion that do not rely on self-report.

A subset of participants in the study "Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568) without any contraindicating factors for brain imaging will undergo three fMRI scans as part of this observational study. The first scan will occur prior to experimental sessions and a second scan will occur after two experimental sessions of MDMA or placebo-assisted psychotherapy. Participants will then be scanned a third time after they have completed a total of three sessions of MDMA-assisted psychotherapy (this includes both subjects that are originally in the MDMA-assisted psychotherapy group, as well as the subjects in the placebo group who will cross over and complete three active MDMA-assisted psychotherapy sessions subsequent to their placebo-assisted psychotherapy. The primary endpoint will be the scan after the second session of MDMA-assisted psychotherapy.

During each scanning session, participants will be undergoing brain scans with functional magnetic imaging (fMRI) while they perform an emotional regulation task that involves observing images possessing negative emotional valence. These images are drawn from, and have their emotional valence validated by, the International Affective Picture System (IAPS). Participants are instructed either to view passively or attempt to reduce the negative affect associated with the images. In addition, resting state brain scans will also be acquired while subjects fixate on a central cross with no explicit task. Heart rate variability will be measured during these resting state scans. The comparison of changes in brain activity during execution of the emotional regulation task (as compared to baseline scans) after receiving psychotherapy with MDMA or placebo, as well as comparison of changes in resting state functional connectivity, are the primary outcome measures. Study observations are intended to assess changes in response to emotion-provoking material at several levels, most notably brain activity in response to anxiety producing images.

While in the scanner, subjects will also listen to prerecorded audio scripts about life stresses for themselves and for another person with instructions to practice compassion for themselves or for others. In yet another task, subjects will perform an attentional bias task where they respond to a dot-probe that appears following a brief presentation of paired images known to produce positive and negative emotions as their brain activity is measured and their reaction times are recorded

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants who can safely undergo and are willing to have fMRI scans and who are enrolled in the study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"
Condition Anxiety
Intervention Other: fMRI
Participants will undergo two to three fMRI scans
Other Name: Functional magnetic resonance imaging
Study Groups/Cohorts Anxiety
Participants enrolled in study ""A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)" who meet further inclusion criteria for fMRI scan
Intervention: Other: fMRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 2, 2016)
12
Original Estimated Enrollment Same as current
Actual Study Completion Date September 30, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Enrolled in the parent study, "A randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness" (NCT02427568)"

Exclusion Criteria:

  • Have a brain mass or lesion
  • Have metal in their skulls,
  • Having brain or heart pacemakers
  • History of major head trauma
  • Have past or present panic or extreme discomfort with being in small enclosed spaces (claustrophobia)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02954562
Other Study ID Numbers MDA1-S1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data from outcome measures will be shared with MAPS and with the investigator conducting the parent study after study completion and data collection. Interested researchers can contact one of the investigators.
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor Multidisciplinary Association for Psychedelic Studies
Collaborators Not Provided
Investigators
Principal Investigator: Michael Silver University of California, Berkeley
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date December 2017