Ketamine for the Treatment of Opioid Use Disorder... — Clinical Trial Details

This parallel, randomised, triple-masked Phase II trial compares intranasal ketamine hydrochloride (60 mg) to saline placebo administered twice weekly for four weeks in participants on buprenorphine with opioid use disorder and comorbid treatment-resistant major depressive disorder.

Primary aims are to evaluate whether adjunctive ketamine improves treatment outcomes for opioid addiction and depressive symptoms; assessments include MADRS, OUD criteria, safety monitoring, and urine drug screens over an ~8-week participation period.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. Between the ages of 18 to 65 years old.
2. Able to provide informed consent.
3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features.
4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale.
5. Fulfill a minimum of 4 of 11 current opioid use disorder criteria by DSM-5.
6. Have used opioids illicitly at least once in the past month.
7. Subjects must be on standard of care pharmacotherapy for OUD (buprenorphine) for at least one month.
8. Subjects taking other psychotropic medications (e.g. antidepressants or non-benzodiazepine anxiolytics) must be maintained on a stable dose for at least four weeks before study initiation.
9. 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.
10. Must consent to random assignment to intranasal ketamine or placebo control.

Exclusion Criteria

Exclusion Criteria:
1. Immediate suicide risk (by Columbia Suicide Severity Rating Scale score of 4 or greater), a history of a suicide attempt in the past year, or by clinician judgment; likely to require hospitalization during the course of the study.
2. Self-reported history of illicit ketamine use, or baseline urine drug testing positive for ketamine.
3. In acute opioid withdrawal (as evidenced by a score of 5 or above on the Clinician Opioid Withdrawal Scale).
4. Meet DSM-5 criteria for current bipolar disorder.
5. Meet DSM-5 criteria for current or history of psychotic spectrum disorders.
6. Women who are pregnant or nursing.
7. Current hypertension as defined by systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
8. Self-reported history of delirium for any cause.
9. History of allergic or other adverse reaction to ketamine.
10. Clinically significant abnormal laboratory values, physical exam findings or 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).
11. Electrocardiogram findings (obtained within thirty days prior to randomization) of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction.

Company

Product

Legal

Ketamine for the Treatment of Opioid Use Disorder and Depression

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators