Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

Brief Summary

This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with posttraumatic stress disorder (PTSD). This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants

The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine

Condition or Disease

  • Posttraumatic Stress Disorder

Phase

Study Design

Study type: Interventional
Status: Withdrawn
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 0 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Aug 01, 2022
Primary Completion: Aug 01, 2023
Completion Date: Aug 01, 2023
Study First Posted: Jul 20, 2021
Last Updated: Feb 10, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person's daily life. PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk. Available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them for adequate dose and duration. People with PTSD can be treated with psychotherapies and pharmacotherapies. In the past decade, there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD

3,4-methylenedioxymethamphetamine is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. A combined treatment of MDMA and therapy may be especially useful for treating PTSD.

This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.

The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT04968938
Acronym: NUMCAP1
Other IDs: NUMCAP1
Study URL: https://ClinicalTrials.gov/show/NCT04968938
Last updated: Jun 17, 2022