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Ketamine for the Treatment of Opioid Use Disorder and Depression

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ClinicalTrials.gov Identifier: NCT04177706
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jennifer Jones, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Depression Opioid-use Disorder Opioid Abuse Drug: Ketamine Hydrochloride Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Ketamine for the Treatment of Concurrent Opioid Use Disorder and Major Depressive Disorder
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (Ketamine) Drug: Ketamine Hydrochloride
Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.

Placebo Comparator: Group B (Placebo) Drug: Placebo
Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.




Primary Outcome Measures :
  1. Percentage of Individuals Completing Informed Consent [ Time Frame: Outcomes will be cumulatively assessed from the time that the first participant is screened through the time that the last participant is enrolled. Estimated time frame of: 23 months. ]
    Primary outcomes will be 1) the percentage of individuals completing informed consent out of the number of individuals eligible on the initial screening.

  2. Percentage of Individuals Completing the Full Protocol [ Time Frame: Outcomes will be cumulatively assessed from the time that the first participant completes informed consent through the time that the last participant completes the final follow-up visit. Estimated time frame of: 23 months. ]
    The other primary outcome will be the percentage of individuals that complete informed consent which complete the full protocol.


Secondary Outcome Measures :
  1. Change in Depression Severity [ Time Frame: Baseline through 4 week follow-up. ]
    Secondary outcomes will include changes in depression severity (as measured on the Montgomery-Asberg Depression Rating Scale), which will be calculated as a change from baseline to 4-week followup. Montgomery Asberg Depression Rating Scale (MADRS; Montgomery, 1979). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. anti-depressants 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:

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.

2. They have a self-reported history of illicit ketamine use, or baseline urine drug testing positive for ketamine.

3. 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.

4. 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.

6. 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.

8. 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).

11. Electrocardiogram (ECG) findings (obtained within thirty days prior to randomization) of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177706


Contacts
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Contact: Melissa Michel 843-792-1901 michelm@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Melissa Michel    843-792-1901    michelem@musc.edu   
Contact: Jennifer Jones, MD    843-792-5594    jonjen@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jennifer Jones, MD Medical University of South Carolina
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Responsible Party: Jennifer Jones, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04177706    
Other Study ID Numbers: 00091292
K12DA031794 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Jones, Medical University of South Carolina:
Ketamine
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Opioid-Related Disorders
Depression
Depressive Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action