Ketamine for the Treatment of Opioid Use Disorder and Depression

NCT04177706 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 00091292K12DA031794
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ketamine

Outcome Measures

Primary Outcomes (2)

• Percentage of Individuals Completing Informed Consent

  Primary outcomes will be 1) the percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.

  Actual time frame of: 23 months.

• Percentage of Individuals Completing the Full Protocol

  The other primary outcome will be the percentage of individuals that complete informed consent which complete the full interventional protocol.

  Actual time frame 23 months.

Secondary Outcomes (1)

• Change in Depression Severity

  Baseline through 4-week interventional visits (8th interventional visit).

Study Arms (2)

Group A (Ketamine)

EXPERIMENTAL

Drug: Ketamine Hydrochloride

Group B (Placebo)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ketamine Hydrochloride DRUG

Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.

Group A (Ketamine)

Placebo DRUG

Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 to 65 years old.
• Able to provide informed consent.
• Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features.
• Score at least 20 on the Montgomery-Asberg Depression Rating Scale.
• Fulfill a minimum of 4 of 11 current opioid use disorder criteria by DSM-5.
• Have used opioids illicitly at least once in the past month.
• Subjects must be on standard of care pharmacotherapy for OUD (buprenorphine) for at least one month.
• Subjects taking other psychotropic medications (e.g. anti-depressants or non benzodiazepine anxiolytics) must be maintained on a stable dose for at least four weeks before study initiation.
• Subjects must be considered to have treatment-refractory MDD as evidenced by failure or only partial response to treatment with at least two standard of care pharmacotherapy antidepressants.
• Must consent to random assignment to intranasal ketamine or placebo control.

You may not qualify if:

• They are considered an immediate suicide risk (by Columbia Suicide Severity Rating Scale of 4 or greater, a history of a suicide attempt in the past year, or by clinician judgment) or felt to be likely to require hospitalization during the course of the study.
• \. They have a self-reported history of illicit ketamine use, or baseline urine drug testing positive for ketamine.
• \. They are in acute opioid withdrawal (as evidenced by a score of 5 or above on the Clinician Opioid Withdrawal Scale). These subjects will be referred for clinical detoxification and pharmacotherapy induction. Subjects may be re-assessed for study eligibility after one month of treatment with a standard of care OUD pharmacotherapy.
• \. Subjects who meet DSM-5 criteria for current bipolar disorder. 5. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders.
• \. Women who are pregnant or nursing. 7. Subjects with current hypertension as defined by a systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg.
• \. Subjects with a self-reported history of delirium for any cause. 9. A history of allergic or other adverse reaction to ketamine. 10. Clinically significant abnormal laboratory values, physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, brain aneurysms, cardiovascular disease, or end-stage renal disease).
• \. Electrocardiogram (ECG) findings (obtained within thirty days prior to randomization) of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Depression; Opioid-Related Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Prinicipal Investigator
• Organization: Medical University of South Carolina

JONJEN@musc.edu

8438761199

Study Officials

• Jennifer Jones, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: December 17, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)