Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090064
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2004-08-24
Brief Title:
MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
Phase II Clinical Trial Testing the Safety and Efficacy of 34-Methylenedioxymethamphetamine MDMA-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic treatment-resistant posttraumatic stress disorder PTSD The main question it aims to answer is Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy
Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart During experimental sessions participants receive an initial dose of 125 mg of MDMA or placebo followed by a dose of 625 mg of MDMA or placebo During this treatment period participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions
The study will test whether MDMA-assisted therapy can be safely given to participants Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period
Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart During experimental sessions participants receive an initial dose of 125 mg of MDMA or placebo followed by a dose of 625 mg of MDMA or placebo During this treatment period participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions
The study will test whether MDMA-assisted therapy can be safely given to participants Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period
Detailed Description:
Posttraumatic stress disorder PTSD occurs in response to a traumatic event or events PTSD is a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs
MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy MDMA has been hypothesized to represent a new class of drugs called entactogens that produce feelings of closeness to others empathy well being and insightfulness Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted therapy may benefit people with PTSD
This randomized double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic treatment-resistant PTSD including veterans Participants were assigned to receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study During these experimental sessions participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 625 mg of MDMA or they received initial and supplemental doses of inactive placebo Psychotherapists and independent raters were blinded to participants treatment conditions This treatment period also consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions
During Stage 2 of the study the blind was broken and participants assigned to receive MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy Participants assigned placebo with therapy during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy Outcome measures were administered two months after the second experimental session in Stage 1 and four to six weeks after the second MDMA-assisted therapy session in Stage 2 A final data-collection session took place at two months after the third experimental session
The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving MDMA-assisted therapy versus placebo with therapy
MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy MDMA has been hypothesized to represent a new class of drugs called entactogens that produce feelings of closeness to others empathy well being and insightfulness Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted therapy may benefit people with PTSD
This randomized double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic treatment-resistant PTSD including veterans Participants were assigned to receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study During these experimental sessions participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 625 mg of MDMA or they received initial and supplemental doses of inactive placebo Psychotherapists and independent raters were blinded to participants treatment conditions This treatment period also consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions
During Stage 2 of the study the blind was broken and participants assigned to receive MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy Participants assigned placebo with therapy during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy Outcome measures were administered two months after the second experimental session in Stage 1 and four to six weeks after the second MDMA-assisted therapy session in Stage 2 A final data-collection session took place at two months after the third experimental session
The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving MDMA-assisted therapy versus placebo with therapy
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