Dr. Alberto Sola is one of the world’s leading experts in medically-based ibogaine treatment; he has more clinical experience with safe and effective ibogaine administration than any other M.D. in the world today.
At Clear Sky Recovery, we are on the cutting-edge of drug rehabilitation treatment with the use of ibogaine. This medically based, clinically managed treatment program is transformative in its ability to alleviate withdrawal symptoms and drug cravings while also lowering the risk of relapse. Because of our expertise and research in the field, we are always eager to share information on new developments in the use of psychotropics to reset drug addictions and other health issues so people can move forward in their lives.
One such development is the recent news that the U.S. Food and Drug Administration (FDA) has approved an application submitted by the Multidisciplinary Association for Psychedelic Studies (MAPS) for an Expanded Access program for MDMA-assisted psychotherapy for post traumatic stress disorder. The goal of this program is to give early access to potentially beneficial investigational therapies for people with serious or life-threatening conditions. Typically, these people have already pursued other avenues of treatment to no avail, and they are unable to participate in Phase 3 clinical trials.
In MAPS’ Expanded Access program, 50 patients will receive the nonprofit organization’s treatment protocol for MDMA-assisted psychotherapy. After working with the first 35 patients, MAPS plans to submit patient data to the FDA with the aim of expanding the program. There will be up to 10 qualifying treatment sites for the program, and patients can apply to a specific site once the program begins. The protocol still has to be approved by the U.S. Drug Enforcement Administration and the Institutional Review Board.
How the Program Would Work
MDMA is a powerful drug. It’s short for 3,4-methylenedioxy-methamphetamine, the drug’s official name. This synthetic drug also has other street names, including ecstasy and molly. Unlike many psychedelic substances, it has a phenylethylamine backbone, which means it has properties associated with both stimulants and hallucinogens. In MDMA-assisted psychotherapy, biological and psychotherapeutic approaches are used to encourage trauma processing, in order to decrease chronic stress reactions to triggers. As the MAPS treatment manual states:
“PTSD involves a deficit in the extinction of fear conditioning. As a result, a combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD because MDMA can attenuate the fear response and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion. While the specific mechanisms involved are not completely understood, MDMA is known to significantly decrease activity in the left amygdala. Studies in healthy volunteers suggest that MDMA alters recognition of and responses to expressions of facial emotion in ways that foster greater rapport, such as making facial expressions of positive emotion easier to recognize and negative emotions harder to detect. This action is compatible with reported effects of MDMA such as reduction in fear or defensiveness and it contrasts with the stimulation of the amygdala observed in animal models of conditioned fear, a state similar to PTSD. Current studies of MDMA-assisted psychotherapy suggest that this reduction in stress-induced activation of the amygdala may be enhanced by interaction with the therapists during and after the MDMA experience.”
The recently approved Expanded Access program encompasses up to three doses of MDMA along with psychotherapy in a controlled clinical setting. Patients do not fill their own prescriptions for the drug or take it at home on their own. The treatment is only available under doctor supervision and administered in therapeutic settings where each patient is supervised by a pair of certified clinicians.
The program is not to be confused with the Phase 3 clinical trials that MAPS also operates; currently, there are 15 sites for these trials in America, Canada, and Israel. The Expanded Access program is limited to patients with moderate to severe PTSD that has withstood all treatment attempts, and the FDA requires that at least one of the pair of therapists should have a medical or clinical doctorate. There is also no control group and patients must pay the costs for their treatment.
MDMA’s roots as a therapeutic drug date back to research studies conducted in the 1970s, but those were halted after it was classified as a Schedule 1 drug in the 1980s. It wasn’t until 2017 that the FDA granted MDMA-assisted psychotherapy the Breakthrough Therapy Designation, which re-opened the door to research. MAPS’ Phase 3 trials are scheduled to finish in 2021, and the FDA could bestow final approval as early as the following year.
These developments are exciting and hold great promise for the future. As MAPS Founder and Executive Director Rick Doblin, Ph.D., said, “We commend the FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD. We are delighted to begin generating real-world evidence about this potential new treatment.”
To learn more about how medically based psychedelic treatment programs work, contact Clear Sky Recovery today. We are the foremost leaders in ibogaine treatment for drug dependency, and our team is made up of experts in the field who are committed to compassionate care for all of our clients.