Opioid Use Disorder study: Ketamine vs Support Group
Official title Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
ClinicalTrials.gov ID: NCT07369089
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to examine the usefulness of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) for individuals with opioid use disorder who are receiving medication treatment. The main question it aims to answer is whether individuals with opioid use disorder who receive Mindfulness-Oriented Recovery Enhancement in combination with Ketamine-Assisted Psychotherapy will demonstrate greater reductions in opioid use and craving than individuals who receive Ketamine-Assisted Psychotherapy with a non-mindfulness support group.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- English-speaking .
- DSM-5 criteria for Opioid Use Disorder (OUD).
- Documented evidence (by urine toxicology) of current illicit drug use (upon screening) or by self-report on the Addiction Severity Index (ASI).
- Men/Women \>/= 18
- Current prescription of a buprenorphine-containing product.
You likely can't join if
- Any significant liver diseases or symptoms of liver disease regardless of liver enzyme levels.
- Asymptomatic alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5x upper limit of normal (ULN).
- Symptomatic ALT or AST \>= 2x ULN.
- AST/ALT \>3 upper limit of normal (ULN)
- Total bilirubin \> 1.5x ULN (Gilbert syndrome is allowed).
- Alkaline phosphatase (ALP) \>2x ULN.
See the full eligibility criteria
- English-speaking .
- DSM-5 criteria for Opioid Use Disorder (OUD).
- Documented evidence (by urine toxicology) of current illicit drug use (upon screening) or by self-report on the Addiction Severity Index (ASI).
- Men/Women \>/= 18
- Current prescription of a buprenorphine-containing product.
- Have a support person that would be able to escort the subject home on the evening of the ketamine dosing session. The use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.).
- Agreement to adhere to Lifestyle Considerations
- Any significant liver diseases or symptoms of liver disease regardless of liver enzyme levels.
- Asymptomatic alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5x upper limit of normal (ULN).
- Symptomatic ALT or AST \>= 2x ULN.
- AST/ALT \>3 upper limit of normal (ULN)
- Total bilirubin \> 1.5x ULN (Gilbert syndrome is allowed).
- Alkaline phosphatase (ALP) \>2x ULN.
- Renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) \ 2 mg of lorazepam-equivalents per day.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.