Clinical Trials Logo

Clinical Trial Summary

This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5 hours later by a supplemental half-dose of 62.5 mg of MDMA. The remaining eight subjects enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25 mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg, with a supplemental dose of 62.5 mg MDMA) during two experimental psychotherapy session, each lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD symptoms was assessed at baseline and two months after the second experimental session using the Clinician Administered PTSD Scale (CAPS) [Blake et al., 1995]. Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study and complete open-label experimental sessions with the fully active dose of MDMA on the same schedule as Stage 1.


Clinical Trial Description

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a person experiences a traumatic event, such as sexual assault, war, or any other life-threatening event. PTSD is a worldwide health problem that severely reduces a person's quality of life and is associated with high rates of psychiatric and medical comorbidity, disability, suffering, and suicide. At least a third of PTSD patients fail to respond to established PTSD psychotherapies. A wider array of effective treatments for PTSD are needed. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment option for PTSD. MDMA is a monoamine releaser that affects serotonin, norepinephrine, and dopamine. MDMA is capable of inducing unique psychopharmacological effects such as decreased feelings of fear, increased feelings of wellbeing, increased sociability and extroversion, increased interpersonal trust, and an alert state of consciousness. In the U.S., MDMA was used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists before it was placed in Schedule I in 1985 as a result of non-medical use. This randomized, double-blind, active placebo-controlled Phase 2 pilot study investigated the safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed by a supplemental half-dose of 62.5 mg of MDMA after 1.5 to 2.5 hours. The remaining eight subjects enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25 mg MDMA with a supplemental half-dose of 12.5 mg MDMA) or a fully active dose (125 mg MDMA with a supplemental half-dose of 62.5 mg MDMA) during two experimental psychotherapy session, each lasting six to eight hours and scheduled three to five weeks apart. Subjects remained with their male/female co-therapist team for the entirety of the study. Upon enrollment, subjects met with their therapist team for three preparatory sessions. After each MDMA-assisted psychotherapy session, subjects met with their therapist team for integrative psychotherapy sessions where subjects processed and connected their thoughts and feelings about the experience. The extent of PTSD symptoms was assessed at baseline and two months after the second experimental session using the Clinician Administered PTSD Scale (CAPS) (Blake et al., 1995). Safety measures, vital signs, and a measurement of psychological distress was assessed during all experimental sessions. Blood pressure and heart rate were assessed periodically during each experimental session. Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study and complete open-label experimental sessions with the fully active dose of MDMA (125 mg and 62.5 mg supplemental) on the same schedule as Stage 1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01689740
Study type Interventional
Source Lykos Therapeutics
Contact
Status Completed
Phase Phase 2
Start date January 17, 2013
Completion date July 16, 2017

See also
  Status Clinical Trial Phase
Completed NCT01443182 - Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma N/A
Completed NCT01507948 - Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD) N/A
Completed NCT02911285 - NAC for Treating Comorbid PTSD and SUD Phase 2
Recruiting NCT02234076 - A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma N/A
Completed NCT01729026 - A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD) Early Phase 1
Completed NCT01464892 - Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma N/A
Completed NCT01406834 - Treatment for the Mental Health Impact of Killing in War N/A
Completed NCT01446146 - Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice N/A
Active, not recruiting NCT03283163 - Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD N/A
Completed NCT02442843 - Non Invasive Brain Stimulation for PTSD Early Phase 1
Completed NCT01888653 - Attention-Bias Modification Treatment for PTSD N/A
Completed NCT01474057 - DElivery of Self Training and Education for Stressful Situations-Primary Care Version Phase 2
Completed NCT00672776 - Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD) Phase 4
Completed NCT03641924 - Cognition and Psychotherapy in PTSD
Completed NCT02397889 - Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD) Phase 2/Phase 3
Completed NCT02322047 - Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders Phase 2
Completed NCT00320138 - Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel Phase 1
Recruiting NCT03833453 - Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD N/A
Completed NCT03833531 - Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD N/A
Completed NCT03529435 - Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related PTSD N/A