NCT04177706

Ketamine for the Treatment of Opioid Use Disorder and Depression

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Ketamine for the Treatment of Concurrent Opioid Use Disorder and Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for concurrent opioid addiction and depression when used in conjunction with buprenorphine treatment. Study medications will be delivered twice per week for four weeks. If you are eligible and you decide to enroll in the study, your participation will last approximately 8 weeks, or 2 months.

Conditions

• Depression
• Opioid-use Disorder
• Opioid Abuse

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.
DRUG	Placebo	Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2019-11-26
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study