Recruiting
Phase 1
Phase 2

Ketamine

Sponsor:

University of Utah

Code:

NCT04892251

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MORE+KAP

MORE

Study Details

Brief summary:

This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.

Conditions

Opioid-use Disorder

Study ID

NCT04892251

Start date

May 20, 2021

Status verified date

Jul, 2023

Completion date

May 30, 2024

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of Opioid Use Disorder
2. Receiving OUD treatment with a buprenorphine formulation

Exclusion Criteria:

1. Previous experience with a mindfulness-based intervention program
2. Pregnancy
3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
4. Prior use of ketamine other than as prescribed by a physician
5. Any of the following medical conditions

Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MORE+KAP

8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions

active comparator: MORE

8 weeks of Mindfulness-Oriented Recovery Enhancement

Interventions

MORE+KAP

Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly

MORE

Mindfulness-Oriented Recovery Enhancement

Primary outcome measure

  • Drug use [ Time Frame: From baseline to 3-month follow-up ]

Central Contacts and Locations

Central contacts

Locations

Center on Mindfulness and Integrative Health Intervention Development

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Research Coordinator

KetaMORE@utah.edu

More Information

Sponsor

University of Utah

Last update posted

Jul 5, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2023-07-05.