Five US Sites Are Now Enrolling Patients for MDMA Clinical Trials

MDMA could soon move out of the nightclub and into the doctor's office. On Thursday, the Multidisciplinary Association for Psychedelic Studies ...

Five US Sites Are Now Enrolling Patients for MDMA Clinical Trials

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Five US Sites Are Now Enrolling Patients for MDMA Clinical Trials

MDMA could soon move out of the nightclub and into the doctor’s office. On Thursday, the Multidisciplinary Association for Psychedelic Studies, a nonprofit focused on researching the medical benefits of psychedelics and marijuana, announced it was ready to begin recruiting volunteers for Phase 3 clinical trials to test whether MDMA, a drug commonly known as ecstasy, could be an effective treatment for post-traumatic stress disorder.

“[T]here are a lot of people that have post-traumatic stress disorder for whom the currently available medications and psychotherapies don’t work,” MAPS founder Rick Doblin explained in a video describing the nonprofit’s research.

MAPS also announced the five sites where it is currently enrolling volunteers for these trials: North Hollywood, California; Boulder, Colorado; Fort Collins, Colorado; New Orleans, Louisiana; and Mount Pleasant, South Carolina. According to a MAPS press release, the organization plans to enroll between 100 and 150 adult volunteers with severe PTSD in the trial. These volunteers will need to live near one of 14 locations in total: the five listed above and nine others throughout the U.S., Canada, and Israel, where enrollment will begin soon.

“MDMA-assisted psychotherapy is unique among trauma treatments,” added Gregory Wells, a principal investigator on the trial. “It allows the participants or the patients to access their traumas in a way that they aren’t overwhelmed by their past experiences. They can address their fear around their trauma.”

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

Enter MDMA

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 psychotherapy may be especially useful for treating PTSD.

According to a MAPS press release, the organization plans to enroll between 100 and 150 adult volunteers with severe PTSD in the trial. These volunteers will need to live near one of 14 locations in total: the five listed above and nine others throughout the U.S., Canada, and Israel, where enrollment will begin soon.

The following sites are now accepting enrollment inquiries from individuals living in or near the following locations: North Hollywood, California; Boulder, Colorado; Fort Collins, Colorado; New Orleans, Louisiana; and Mount Pleasant, South Carolina. Contact information for enrollment inquiries is available at clinicaltrials.gov.

Additional sites to start enrollment soon include: San Francisco Insight and Integration Center (San Francisco, Calif.); University of California, San Francisco; Trauma Research Foundation (Boston, Mass.); New York University; Affective Care (New York, NY); Providence Health Center (Vancouver, BC, Canada); Dr. Simon Amar LLC (Montreal, Québec, Canada); Be’er Ya’akov Mental Health Center (Israel); and Sheba/Tel Hashomer (Israel).

Each volunteer will undergo a 12-week-long treatment plan consisting of 15 sessions, including three experimental sessions during which some volunteers will undergo MDMA-assisted psychotherapy while others will receive a placebo. The researchers will then review the data from this Phase 3 clinical trial before beginning a second Phase 3 trial, which will also enroll 100 to 150 participants. Phase 3 is the final trial stage before the U.S

Food and Drug Administration can clear a drug for medical use, so if these trials produce positive results, the next step could be FDA approval of an MDMA-assisted psychotherapy treatment for PTSD..

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