Trials / Terminated
TerminatedNCT05193318
KAP for Depression in Abstinent Opioid Users
Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Medical University of South Carolina · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Opioid Use Disorder, Severe, in Sustained Remission
- Opioid Use Disorder, Severe, in Early Remission
- Major Depressive Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ketamine-assisted psychotherapy | Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session. |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2023-03-20
- Completion
- 2023-03-20
- First posted
- 2022-01-14
- Last updated
- 2024-05-06
- Results posted
- 2024-05-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05193318. Inclusion in this directory is not an endorsement.