Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02876172
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2016-08-16
Brief Title:
MDMA-Assisted Cognitive-Behavioral Conjoint Therapy CBCT in Dyads in Which 1 Member Has Chronic PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
A Phase 12 Open-Label Treatment Development Study of Methylenedioxymethamphetamine MDMA-Assisted Cognitive-Behavioral Conjoint Therapy CBCT in Dyads in Which 1 Member Has Chronic 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 12 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners intimate or non-intimate significant other who does not have a current diagnosis of PTSD in order to explore whether combined treatment is effective Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT During the first experimental session both participants will receive 75 mg of MDMA followed 15 to 2 hours later by an optional supplemental half-dose of 375 mg During the second experimental session an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 375 mg The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants
Detailed Description:
PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war disaster sexual abuse violence terrorism and accidents PTSD negatively impacts a persons daily life resulting in relationship difficulties difficulty in finding and maintaining a job reduced cognitive and psychosocial functioning substance abuse high-cost healthcare use and increased depression and suicide risk
34-methylenedioxymethamphetamine is a drug that releases serotonin norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin arginine vasopressin and cortisol In the context of psychotherapy MDMA has been noted to reduce defenses and fear of emotional injury while enhancing communication and capacity for introspection
Cognitive-Behavioral Conjoint Therapy CBCT for PTSD is a three-phase 15-session manualized treatment This Phase 12 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners intimate or non-intimate significant other who does not have a current diagnosis of PTSD in order to explore whether combined treatment is effective Each therapy team will have one therapist trained and experienced in MDMA assisted therapy and one therapist trained and experienced in CBCT During the first experimental session both participants will receive 75 mg of MDMA followed 15 to 2 hours later by an optional supplemental half-dose of 375 mg During the second experimental session an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 375 mg The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 CAPS-5 total severity scores in PTSD participants
34-methylenedioxymethamphetamine is a drug that releases serotonin norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin arginine vasopressin and cortisol In the context of psychotherapy MDMA has been noted to reduce defenses and fear of emotional injury while enhancing communication and capacity for introspection
Cognitive-Behavioral Conjoint Therapy CBCT for PTSD is a three-phase 15-session manualized treatment This Phase 12 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners intimate or non-intimate significant other who does not have a current diagnosis of PTSD in order to explore whether combined treatment is effective Each therapy team will have one therapist trained and experienced in MDMA assisted therapy and one therapist trained and experienced in CBCT During the first experimental session both participants will receive 75 mg of MDMA followed 15 to 2 hours later by an optional supplemental half-dose of 375 mg During the second experimental session an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 375 mg The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 CAPS-5 total severity scores in PTSD participants
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