Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
Study NCT ID:
NCT05193318
Status:
TERMINATED
Last Update Posted:
2024-05-06
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
KAP for Depression in Abstinent Opioid Users
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary Investigator leaving institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KReDO
Brief Summary:
The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: