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Status:

RECRUITING

MDMA-Assisted CBCT for PTSD vs CBCT RCT

Lead Sponsor:

Remedy

Collaborating Sponsors:

Remedy Institute

Conditions:

Post Traumatic Stress Disorder

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumati...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Participant with PTSD
  • Participant with PTSD
  • Meet criteria for PTSD
  • Have a close other person who is able and willing to participate in this study
  • Are at least 18 years old
  • Are a resident of Ontario and live within the Greater Toronto Area (GTA)
  • Are in good physical health
  • Are proficient in speaking and reading English
  • Are willing to have all visits audio and video recorded
  • Are able to swallow pills
  • Agree to all study rules and commit to all medical and therapy visits
  • If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
  • Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
  • Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA
  • Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
  • Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact
  • Agree to inform the researchers within 48 hours of any medical conditions and procedures
  • Agree to not participate in any other clinical trials during this study
  • Close Significant Other
  • Have a close other person who meets criteria for PTSD and is able and willing to participate in this study
  • Are at least 18 years old
  • Are a resident of Ontario and live within the Greater Toronto Area (GTA)
  • Are in good physical health
  • Are proficient in speaking and reading English
  • Are willing to have all visits audio and video recorded
  • Are able to swallow pills
  • Agree to all study rules and commit to all medical and therapy visits
  • If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
  • Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
  • Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA
  • Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
  • Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact
  • Agree to inform the researchers within 48 hours of any medical conditions and procedure
  • Agree to not participate in any other clinical trials during this study
  • Exclusion Criteria
  • Participant with PTSD
  • Are pregnant or could become pregnant and not using birth control
  • Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder
  • Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
  • Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
  • Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
  • Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
  • Have liver disease with symptoms
  • Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)
  • Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
  • Weigh less than 48 kg
  • Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)
  • Require ongoing therapy with a psychiatric medication
  • Have a current eating disorder with active purging
  • Have current major depressive disorder with psychotic features
  • Are a serious risk to others
  • Have recently received Electroconvulsive Therapy (ECT)
  • Have recently engaged in ketamine-assisted therapy or used ketamine
  • Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
  • Have recently used "Ecstasy" (material represented as containing MDMA)
  • Are not able to give adequate informed consent
  • Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial
  • Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
  • Close Significant Other
  • Meet criteria for PTSD
  • Are pregnant or could become pregnant and not using birth control
  • Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder
  • Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
  • Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
  • Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
  • Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
  • Have liver disease with symptoms
  • Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)
  • Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
  • Weigh less than 48 kg
  • Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)
  • Require ongoing therapy with a psychiatric medication
  • Have a current eating disorder with active purging
  • Have current major depressive disorder with psychotic features
  • Are a serious risk to others
  • Have recently received Electroconvulsive Therapy (ECT)
  • Have recently engaged in ketamine-assisted therapy or used ketamine
  • Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
  • Have recently used "Ecstasy" (material represented as containing MDMA)
  • Are not able to give adequate informed consent
  • Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial
  • Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders

Exclusion

    Key Trial Info

    Start Date :

    November 15 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2026

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT06044675

    Start Date

    November 15 2024

    End Date

    December 31 2026

    Last Update

    November 26 2024

    Active Locations (1)

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    Remedy Institute

    Toronto, Ontario, Canada, M6G 1L5