US News & World Report
A small study suggests that the illicit "club drug" Ecstasy may have one positive use: making psychotherapy more effective for people with post-traumatic stress disorder (PTSD).
The drug, also known by its chemical acronym MDMA, appears to benefit patients for whom standard treatments have failed. But experts stressed that the study is preliminary and safety issues must be resolved before any recommendations can be made.
"PTSD treatment involves revisiting the trauma in a therapeutic setting, but many patients become overwhelmed by anxiety or numb themselves emotionally, and so they can't really successfully engage," said study lead researcher Dr. Michael Mithoefer, a psychiatrist in private practice in Charleston, S.C. "But what we found is that the MDMA seemed to temporarily decrease fear without blunting emotions, and so it helped patients better process their grief."
In PTSD, the sufferer typically "relives" the trauma via flashbacks or in other ways, such as becoming hyper-vigilant to everyday sounds. Other mental health issues include depression, anxiety disorder, adjustment disorder and alcohol and substance abuse.
Mithoefer and his colleagues studied 20 patients who'd had PTSD for an average of 19 years but had failed to get relief from psychotherapy and medications. The study participants underwent two eight-hour psychotherapy sessions scheduled about a month apart, with 12 patients taking MDMA, and eight taking a placebo. Subjects were also given psychotherapy on a weekly basis before and after each experimental session. An independent psychologist evaluated each patient's symptoms of PTSD prior to and after the sessions.
At the end of the trial, more than 80 percent of the patients who received a combination of MDMA and psychotherapy no longer met the diagnostic criteria for post-traumatic stress disorder, compared with only 25 percent of the placebo group. In addition, the three patients who reported being unable to work due to post-traumatic stress disorder were able to return to work following treatment with MDMA.
During the trial, none of the patients had any drug-related side effects or neurocognitive problems related to the drug, the researchers reported.
The study is the first completed randomized, double-blinded clinical trial to evaluate MDMA as an adjunct to psychotherapy in any patient population, the researchers said. It was sponsored by the Multidisciplinary Association for Psychedelic Studies, a Belmont, Mass.-based nonprofit group that focuses on the medicinal uses of psychedelic drugs.
The phase 2 study, the second of three phases of research required by the federal government before approving a drug for a specific use, was published online July 19 in the Journal of Psychopharmacology.
Before MDMA began to be used recreationally under the street name Ecstasy, many psychiatrists and other therapists in the United States and Europe used the compound as a catalyst to psychotherapy, the study authors noted. However, the drug has been illegal in the United Kingdom since 1977 and was criminalized in the United States in 1985.
People with post-traumatic stress disorder who may want to experiment with the drug should know it can be dangerous when not used properly, Mithoefer said. "It needs to be taken in a therapeutic setting with careful monitoring and a lot of follow-up to help patients integrate the experience successfully," he said. "I've had patients with PTSD outside the study tell me that they've used MDMA at a party and had bad experiences, because when feelings about the trauma came up, they weren't prepared to deal with them."
One important limitation of the study, Mithoefer said, was that most participants guessed accurately whether they were in the treatment or the placebo group, and trial investigators could detect raised blood pressure and other symptoms in the MDMA group. He added that an upcoming phase 2 trial -- looking at the effects of MDMA-assisted therapy on veterans with PTSD -- will hopefully avoid this problem, since all patients will receive the drug, but in different dosages.
Another PTSD researcher said the study results were intriguing but added that important safety concerns need to be resolved.
"Some animal studies have shown that MDMA is a neurotoxin, so there's a lot of work that needs to be done to make sure there are no long-term side effects," said Keith A. Young, co-director of the Neuropsychiatry Research Program at Texas A&M Health Science Center College of Medicine.
Young, who is also core leader of the VA Center of Excellence for Research on Returning War Veterans in Waco, predicted that the findings would spur more research. "A lot of clinical scientists will be interested in seeing this data," he said.
The drug, also known by its chemical acronym MDMA, appears to benefit patients for whom standard treatments have failed. But experts stressed that the study is preliminary and safety issues must be resolved before any recommendations can be made.
"PTSD treatment involves revisiting the trauma in a therapeutic setting, but many patients become overwhelmed by anxiety or numb themselves emotionally, and so they can't really successfully engage," said study lead researcher Dr. Michael Mithoefer, a psychiatrist in private practice in Charleston, S.C. "But what we found is that the MDMA seemed to temporarily decrease fear without blunting emotions, and so it helped patients better process their grief."
In PTSD, the sufferer typically "relives" the trauma via flashbacks or in other ways, such as becoming hyper-vigilant to everyday sounds. Other mental health issues include depression, anxiety disorder, adjustment disorder and alcohol and substance abuse.
Mithoefer and his colleagues studied 20 patients who'd had PTSD for an average of 19 years but had failed to get relief from psychotherapy and medications. The study participants underwent two eight-hour psychotherapy sessions scheduled about a month apart, with 12 patients taking MDMA, and eight taking a placebo. Subjects were also given psychotherapy on a weekly basis before and after each experimental session. An independent psychologist evaluated each patient's symptoms of PTSD prior to and after the sessions.
At the end of the trial, more than 80 percent of the patients who received a combination of MDMA and psychotherapy no longer met the diagnostic criteria for post-traumatic stress disorder, compared with only 25 percent of the placebo group. In addition, the three patients who reported being unable to work due to post-traumatic stress disorder were able to return to work following treatment with MDMA.
During the trial, none of the patients had any drug-related side effects or neurocognitive problems related to the drug, the researchers reported.
The study is the first completed randomized, double-blinded clinical trial to evaluate MDMA as an adjunct to psychotherapy in any patient population, the researchers said. It was sponsored by the Multidisciplinary Association for Psychedelic Studies, a Belmont, Mass.-based nonprofit group that focuses on the medicinal uses of psychedelic drugs.
The phase 2 study, the second of three phases of research required by the federal government before approving a drug for a specific use, was published online July 19 in the Journal of Psychopharmacology.
Before MDMA began to be used recreationally under the street name Ecstasy, many psychiatrists and other therapists in the United States and Europe used the compound as a catalyst to psychotherapy, the study authors noted. However, the drug has been illegal in the United Kingdom since 1977 and was criminalized in the United States in 1985.
People with post-traumatic stress disorder who may want to experiment with the drug should know it can be dangerous when not used properly, Mithoefer said. "It needs to be taken in a therapeutic setting with careful monitoring and a lot of follow-up to help patients integrate the experience successfully," he said. "I've had patients with PTSD outside the study tell me that they've used MDMA at a party and had bad experiences, because when feelings about the trauma came up, they weren't prepared to deal with them."
One important limitation of the study, Mithoefer said, was that most participants guessed accurately whether they were in the treatment or the placebo group, and trial investigators could detect raised blood pressure and other symptoms in the MDMA group. He added that an upcoming phase 2 trial -- looking at the effects of MDMA-assisted therapy on veterans with PTSD -- will hopefully avoid this problem, since all patients will receive the drug, but in different dosages.
Another PTSD researcher said the study results were intriguing but added that important safety concerns need to be resolved.
"Some animal studies have shown that MDMA is a neurotoxin, so there's a lot of work that needs to be done to make sure there are no long-term side effects," said Keith A. Young, co-director of the Neuropsychiatry Research Program at Texas A&M Health Science Center College of Medicine.
Young, who is also core leader of the VA Center of Excellence for Research on Returning War Veterans in Waco, predicted that the findings would spur more research. "A lot of clinical scientists will be interested in seeing this data," he said.
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