Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01689740
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2012-09-07
Brief Title:
Randomized Double-blind Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic Treatment-Resistant Posttraumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 15 to 25 hours later by a supplemental half-dose of 625 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 125 mg MDMA or a fully active dose of MDMA 125 mg with a supplemental dose of 625 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
Detailed 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 persons 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
34-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 US 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 625 mg of MDMA after 15 to 25 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 125 mg MDMA or a fully active dose 125 mg MDMA with a supplemental half-dose of 625 mg MDMA during two experimental psychotherapy session each lasting six to eight hours and scheduled three to five weeks apart
Subjects remained with their malefemale 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 625 mg supplemental on the same schedule as Stage 1
34-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 US 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 625 mg of MDMA after 15 to 25 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 125 mg MDMA or a fully active dose 125 mg MDMA with a supplemental half-dose of 625 mg MDMA during two experimental psychotherapy session each lasting six to eight hours and scheduled three to five weeks apart
Subjects remained with their malefemale 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 625 mg supplemental on the same schedule as Stage 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None