CompletedPhase 2

Ketamine for the Treatment of Opioid Use Disorder and Depression

United States21 participantsStarted 2020-12-17

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Percentage of Individuals Completing Informed Consent

Timeframe: Actual time frame of: 23 months.

Percentage of Individuals Completing the Full Protocol

Timeframe: Actual time frame 23 months.

Trial details

NCT IDNCT04177706

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-21

Results submitted2024-02-27

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