MDMA-Assisted CBCT for PTSD vs CBCT RCT

NCT ID: NCT06044675

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-31

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-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery.

CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads.

MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness.

This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDMA-Assisted CBCT Condition

Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered in two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.

Group Type: EXPERIMENTAL

MDMA assisted psychotherapy

Intervention Type: DRUG

This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.

CBCT-Only Condition

Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD. Dyads who have undergone the CBCT-Only condition will have the option to do a crossover and have the two MDMA sessions after follow-up.

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: BEHAVIORAL

A manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.

Interventions

MDMA assisted psychotherapy

This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.

Intervention Type: DRUG

Psychotherapy

A manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.

Intervention Type: BEHAVIORAL

Other Intervention Names

MDMA-assisted CBCT; CBCT

Eligibility Criteria

Inclusion Criteria

• Participant with PTSD

1. Participant with PTSD

2. Meet criteria for PTSD

3. Have a close other person who is able and willing to participate in this study

4. Are at least 18 years old

5. Are a resident of Ontario and live within the Greater Toronto Area (GTA)

6. Are in good physical health

7. Are proficient in speaking and reading English

8. Are willing to have all visits audio and video recorded

9. Are able to swallow pills

10. Agree to all study rules and commit to all medical and therapy visits

11. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist

12. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study

13. 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

14. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant

15. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact

16. Agree to inform the researchers within 48 hours of any medical conditions and procedures

17. Agree to not participate in any other clinical trials during this study

• Close Significant Other

1. Have a close other person who meets criteria for PTSD and is able and willing to participate in this study

2. Are at least 18 years old

3. Are a resident of Ontario and live within the Greater Toronto Area (GTA)

4. Are in good physical health

5. Are proficient in speaking and reading English

6. Are willing to have all visits audio and video recorded

7. Are able to swallow pills

8. Agree to all study rules and commit to all medical and therapy visits

9. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist

10. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study

11. 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

12. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant

13. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact

14. Agree to inform the researchers within 48 hours of any medical conditions and procedure

15. Agree to not participate in any other clinical trials during this study

Exclusion Criteria

• Participant with PTSD

1. Are pregnant or could become pregnant and not using birth control

2. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder

3. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)

4. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable

5. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement

6. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication

7. Have liver disease with symptoms

8. 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)

9. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)

10. Weigh less than 48 kg

11. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)

12. Require ongoing therapy with a psychiatric medication

13. Have a current eating disorder with active purging

14. Have current major depressive disorder with psychotic features

15. Are a serious risk to others

16. Have recently received Electroconvulsive Therapy (ECT)

17. Have recently engaged in ketamine-assisted therapy or used ketamine

18. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)

19. Have recently used "Ecstasy" (material represented as containing MDMA)

20. Are not able to give adequate informed consent

21. 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

22. 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

1. Meet criteria for PTSD

2. Are pregnant or could become pregnant and not using birth control

3. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder

4. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)

5. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable

6. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement

7. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication

8. Have liver disease with symptoms

9. 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)

10. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)

11. Weigh less than 48 kg

12. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)

13. Require ongoing therapy with a psychiatric medication

14. Have a current eating disorder with active purging

15. Have current major depressive disorder with psychotic features

16. Are a serious risk to others

17. Have recently received Electroconvulsive Therapy (ECT)

18. Have recently engaged in ketamine-assisted therapy or used ketamine

19. Have current substance use disorder with physiological dependence (not including caffeine or nicotine)

20. Have recently used "Ecstasy" (material represented as containing MDMA)

21. Are not able to give adequate informed consent

22. 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

23. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Remedy Institute

OTHER

Sponsor Role: collaborator

Remedy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Uy, MD

Role: PRINCIPAL_INVESTIGATOR

Remedy Institute

Anne Wagner, PhD

Role: STUDY_CHAIR

Remedy Institute

Locations

Remedy Institute

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Song Ge

Role: CONTACT

research@remedyinstitute.ca

4372914747

Anne Wagner, C.Psych.

Role: CONTACT

dr.wagner@remedyinstitute.ca

647-362-8822 ext. 102

Facility Contacts

Hajara Abdirahman, BS

Role: primary

Other Identifiers

ICAPT1

Identifier Type: -

Identifier Source: org_study_id