Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066853
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-09-27
Brief Title:
MDMA-assisted Therapy for Fibromyalgia
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Spaulding Rehabilitation Hospital
Study Overview
Official Title:
Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-assisted Therapy for Fibromyalgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia is a debilitating chronic pain disorder Based on prior research with MDMA it can be hypothesized MDMA-assisted therapy in fibromyalgia patients may increase the range of positive emotions interpersonal trust and heighten the state of empathic rapport that can lead to an enhanced patient-clinician interaction and to initiate reattribution processes targeting dysfunctional thoughts towards pain Therapeutic alliance ie a positive patient-clinician relationship is already acknowledged as an essential component for MDMA-assisted therapy Despite its importance the patient-clinician interaction and the neuroscience supporting patientclinician therapeutic alliance has received almost no attention in MDMA research The investigators will examine the potential therapeutic benefit of MDMA-assisted therapy for fibromyalgia Additionally this study will also target secondary objectives including the investigation of the clinical and physiological response ie brain-to-brain concordance supporting enhanced patient-clinician therapeutic alliance in fibromyalgia patients The study includes two Experimental Sessions of therapy with MDMA combined with neuroimaging along integrative therapy baseline neuroimaging and a 3 month follow up
Detailed Description:
If the participant agrees to engage in this research study they will be asked to complete the following study visits
Screening Visit 1
At this visit the participant will review and sign the consent form If informed consent is given the investigators will proceed to screening During screening the study personnel will decide if eligibility criteria are met The study staff will ask about medical and psychiatric history medications and any other conditions They will then further assess eligibility through clinical lab tests a drug screen and pregnancy test for those able to become pregnant The drug screen will include at minimum amphetamines barbiturates cocaine opioids cannabinoids and benzodiazepines Participants will also complete a symptom-directed physical exam and vitals blood pressure temperature and respiratory and heart rate will be assessed An electrocardiogram ECG a test that measures the rhythm and rate of the heart will be performed Additional cardiovascular evaluation and risk mitigation will be completed to determine eligibility if the participant has cardiac risk factors but no other evidence of significant cardiovascular or cerebrovascular disease
At the screening visit study staff will measure the participants responses to pressure pain using an inflatable cuff that is placed on the lower leg Different pressure intensities to inflate the cuff will be used The participant will be asked to complete several questionnaires that will assess personality and other traits along with questionnaires to assess pain Participants found eligible after the screening visit will be enrolled in the study
All participants are required to identify a support person This person will be responsible for staying with the participant on the evenings of the experimental sessions and will meet with the therapy team to receive training regarding their role All participants will also be required to identify an escort who will accompany the participant to and from the study site for each experimental session This may be the same person as the support person or it may be someone else
Baseline EEG and MRI Visits 2 and 3
Following enrollment participants will complete a baseline electroencephalography EEG scan followed by a functional magnetic resonance imaging fMRI scan At the EEG scan participants will be asked to view and reflect on various statements and to complete a cuff pressure task in which they will receive various cuff pressures to their left leg While participants are doing these tasks the activity of the brain will be monitored using EEG and vitals will be measured
At the fMRI scan participants will be asked to change out of their clothes and into an MRI-compatible hospital gown and pants to ensure safety They will be asked to remove any metal objects including jewelry any piercings and hair pins Participants will be given earplugs to reduce the loud noises of the MRI machine Participants will be able to communicate with the study doctors and MRI staff during the procedures While in the scanner participants will complete the same tasks as described in the EEG session The clinician will be positioned in a different scanner and video transfer between the two scanners will enable the patient and clinician to view one anothers face on a screen for some of the tasks
In order to quality check the interaction between the patient and the clinician parts of these scans will be recorded on a videotape
Preparatory Period Visits 4-6
Following baseline scans participants will undergo three weekly preparatory sessions with each session lasting about 90 minutes During these visits participants will meet with their therapy team to learn more about fibromyalgia and develop rapport with their clinicians The therapy team will help prepare participants for the experimental visits During this period participants will undergo medication tapering if necessary Prior to the final preparatory session the investigators will do a final assessment of eligibility and confirm that all medication tapering is complete
Experimental Period Visits 7-12
The experimental period will consist of two MDMA-assisted therapy sessions and four integrative sessions Each of the experimental sessions will last for about 8 hours At the beginning of the experimental sessions participants will complete a symptom-directed physical exam a urine drug screen and a pregnancy test if applicable These tests must be negative for the visit to proceed Participants will be asked to confirm they have not consumed nicotine or caffeine for the past 2 hours and have not consumed food for the past 10 hours They will complete several questionnaires and will have a quick interview with the therapy team to discuss goals intentions and concerns related to the MDMA-assisted therapy session Vitals will be recorded just before drug administration
Participants will receive an initial dose of 100 mg of MDMA They will swallow capsules of study drug with water under the supervision of study staff The participant will sit or recline on comfortable furnishings and complete MDMA-assisted therapy with their clinicians A supplemental dose of 50 mg of study drug will be administered 15 to 2 hours after the initial dose as seen fit by the therapy team
About three hours post initial drug administration participants will have an EEG Visit 7 or fMRI Visit 10 scan Throughout these scans participants will remain in contact with their therapy team These scans will be include the same tasks and procedures as the baseline scans Following the EEG or fMRI scan participants will remain with the therapy team until the study drug effects have subsided their vitals are stable and their support person or escort has arrived
Following each experimental visit there will be two integrative sessions which will consist of 90 minutes of therapy At these visits participants will discuss and review events from the experimental session One of the integrative visits Visit 11 will include an EEG scan during the therapy session
Follow-up Visit 13
About four weeks after the final integration session participants will be asked to complete a virtual follow-up visit to complete a short interview and answer some final questionnaires
Screening Visit 1
At this visit the participant will review and sign the consent form If informed consent is given the investigators will proceed to screening During screening the study personnel will decide if eligibility criteria are met The study staff will ask about medical and psychiatric history medications and any other conditions They will then further assess eligibility through clinical lab tests a drug screen and pregnancy test for those able to become pregnant The drug screen will include at minimum amphetamines barbiturates cocaine opioids cannabinoids and benzodiazepines Participants will also complete a symptom-directed physical exam and vitals blood pressure temperature and respiratory and heart rate will be assessed An electrocardiogram ECG a test that measures the rhythm and rate of the heart will be performed Additional cardiovascular evaluation and risk mitigation will be completed to determine eligibility if the participant has cardiac risk factors but no other evidence of significant cardiovascular or cerebrovascular disease
At the screening visit study staff will measure the participants responses to pressure pain using an inflatable cuff that is placed on the lower leg Different pressure intensities to inflate the cuff will be used The participant will be asked to complete several questionnaires that will assess personality and other traits along with questionnaires to assess pain Participants found eligible after the screening visit will be enrolled in the study
All participants are required to identify a support person This person will be responsible for staying with the participant on the evenings of the experimental sessions and will meet with the therapy team to receive training regarding their role All participants will also be required to identify an escort who will accompany the participant to and from the study site for each experimental session This may be the same person as the support person or it may be someone else
Baseline EEG and MRI Visits 2 and 3
Following enrollment participants will complete a baseline electroencephalography EEG scan followed by a functional magnetic resonance imaging fMRI scan At the EEG scan participants will be asked to view and reflect on various statements and to complete a cuff pressure task in which they will receive various cuff pressures to their left leg While participants are doing these tasks the activity of the brain will be monitored using EEG and vitals will be measured
At the fMRI scan participants will be asked to change out of their clothes and into an MRI-compatible hospital gown and pants to ensure safety They will be asked to remove any metal objects including jewelry any piercings and hair pins Participants will be given earplugs to reduce the loud noises of the MRI machine Participants will be able to communicate with the study doctors and MRI staff during the procedures While in the scanner participants will complete the same tasks as described in the EEG session The clinician will be positioned in a different scanner and video transfer between the two scanners will enable the patient and clinician to view one anothers face on a screen for some of the tasks
In order to quality check the interaction between the patient and the clinician parts of these scans will be recorded on a videotape
Preparatory Period Visits 4-6
Following baseline scans participants will undergo three weekly preparatory sessions with each session lasting about 90 minutes During these visits participants will meet with their therapy team to learn more about fibromyalgia and develop rapport with their clinicians The therapy team will help prepare participants for the experimental visits During this period participants will undergo medication tapering if necessary Prior to the final preparatory session the investigators will do a final assessment of eligibility and confirm that all medication tapering is complete
Experimental Period Visits 7-12
The experimental period will consist of two MDMA-assisted therapy sessions and four integrative sessions Each of the experimental sessions will last for about 8 hours At the beginning of the experimental sessions participants will complete a symptom-directed physical exam a urine drug screen and a pregnancy test if applicable These tests must be negative for the visit to proceed Participants will be asked to confirm they have not consumed nicotine or caffeine for the past 2 hours and have not consumed food for the past 10 hours They will complete several questionnaires and will have a quick interview with the therapy team to discuss goals intentions and concerns related to the MDMA-assisted therapy session Vitals will be recorded just before drug administration
Participants will receive an initial dose of 100 mg of MDMA They will swallow capsules of study drug with water under the supervision of study staff The participant will sit or recline on comfortable furnishings and complete MDMA-assisted therapy with their clinicians A supplemental dose of 50 mg of study drug will be administered 15 to 2 hours after the initial dose as seen fit by the therapy team
About three hours post initial drug administration participants will have an EEG Visit 7 or fMRI Visit 10 scan Throughout these scans participants will remain in contact with their therapy team These scans will be include the same tasks and procedures as the baseline scans Following the EEG or fMRI scan participants will remain with the therapy team until the study drug effects have subsided their vitals are stable and their support person or escort has arrived
Following each experimental visit there will be two integrative sessions which will consist of 90 minutes of therapy At these visits participants will discuss and review events from the experimental session One of the integrative visits Visit 11 will include an EEG scan during the therapy session
Follow-up Visit 13
About four weeks after the final integration session participants will be asked to complete a virtual follow-up visit to complete a short interview and answer some final questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None