This terminated interventional trial (n=0) was conducted by the Medical University of South Carolina. The study aimed to examine whether ketamine, along with psychotherapy, is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids for at least three months.
Participants, aged between 18 to 64 years, who met DSM-5 criteria for Major Depressive Disorder and opioid use disorder in early or sustained remission were eligible. They received eight weekly intramuscular injections of ketamine hydrochloride along with psychotherapy sessions. The study assessed various outcome measures, including the Montgomery Asberg Depression Rating Scale, Beck Depression Inventory, Visual Analog Scale for opioid craving, Generalized Anxiety Disorder-7, and others.
The study, which started on January 13, 2022, and was terminated on March 20, 2023, involved 5 participants. It was designed as an interventional, phase 2 trial with a single-group assignment. The study location was Charleston, South Carolina, United States.
Trial Details
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.NCT Number NCT05193318
Sponsors & Collaborators
Medical University of South CarolinaThe Medical University of South Carolina (MUSC) partnered with MAPS to create a psychedelic research centre to study the therapeutic effects of psychedelic drugs on mental illness.