KAP for Depression in Abstinent Opioid Users (KReDO)

• ClinicalTrials.gov Identifier: NCT05193318
• Recruitment Status: Recruiting
• First Posted: January 14, 2022
• Last Update Posted: February 24, 2022
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Eric Dobson, MD, Medical University of South Carolina

Tracking Information

• First Submitted Date: December 14, 2021
• First Posted Date: January 14, 2022
• Last Update Posted Date: February 24, 2022
• Actual Study Start Date: January 13, 2022
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 30, 2021)

Montgomery Asberg Depression Rating Scale [ Time Frame: Change from baseline measured at week 9 ]

Clinician-administered rating of depressive symptoms; minimum score of 0, maximum score of 60; a decrease in score means a better outcome (less depressed)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 30, 2021)

• Beck Depression Inventory [ Time Frame: Change from baseline measured at week 1-9, 10, 12, and 16 ]
  Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
• Visual Analog Scale (VAS) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Measure of subjective level of opioid craving; maximum score of 100 and minumum score of 0 with higher scores meaning worse outcome (more cravings)
• Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)
• Mystical Experience Questionnaire (MEQ) [ Time Frame: Measured at week 1-8 ]
  Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense experience
• Brief Pain Inventory (BPI) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Measure of pain and quality of life; maximum score of 10 and minimum of 1 with higher scores indicating worse outcome (more pain)
• Insomnia Severity Index (ISI) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Assesses insomnia and sleep quality; maximum score of 28 and minimum score of 0 with higher score indicating worse outcome (worse sleep)
• Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Assesses aspects of mindfulness; maximum score of 40 and minimum score of 8 with higher scores indicating better outcome (more mindfulness)
• PTSD Checklist (PCL-5; PTSD checklist 5) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)
• Timeline Follow-back (TLFB) [ Time Frame: Measured at week 1-9, 10, 12, and 16 ]
  Measure of Substance Use; maximum number of substance use days per week is 7 and minimum is 0 with higher number indicating worse outcomes (more substance use)
• Montgomery Asberg Depression Rating Scale [ Time Frame: Change from baseline measured at week 2-8, 10, 12, and 16 ]
  Clinician-administered rating of depressive symptoms; minimum score of 0, maximum score of 60; a decrease in score means a better outcome (less depressed)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: KAP for Depression in Abstinent Opioid Users
• Official Title: Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
• Brief Summary: The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Opioid Use Disorder, Severe, in Sustained Remission
• Opioid Use Disorder, Severe, in Early Remission
• Major Depressive Disorder

Intervention

Drug: Ketamine-assisted psychotherapy

Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.

Study Arms

Experimental: Ketamine-assisted psychotherapy

Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.

Intervention: Drug: Ketamine-assisted psychotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 30, 2021): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2022
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

A subject may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first experimental session:

1. Between the ages of 18 to 64 years old.
2. Able to provide informed consent.
3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview.
4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression).
5. Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview.
6. Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria apply:

1. They are considered an immediate suicide risk by clinician assessment, self-reports a suicide attempt within the past year, or felt to be likely to require hospitalization during the study.
2. Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
3. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
4. Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.
5. Subjects who report use of ketamine >20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission.
6. Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the interventional phase of the study.
7. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
8. A history of allergic or other adverse reaction to ketamine (or its excipients).
9. Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).
10. QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded.
11. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
12. Subjects with kidney or liver impairment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Eric T Dobson, MD; 843-729-1445; dobsoner@musc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05193318
• Other Study ID Numbers: Pro00115696
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eric Dobson, MD, Medical University of South Carolina
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of South Carolina
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eric T Dobson, MD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: February 2022