KReDO: KAP for Depression in Abstinent Opioid Users

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05193318

Collaborator

(none)

Enrollment

Location

Arm

17.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder, Severe, in Sustained Remission Opioid Use Disorder, Severe, in Early Remission Major Depressive Disorder	Drug: Ketamine-assisted psychotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users

Actual Study Start Date :

Jan 13, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

Drug: Ketamine-assisted psychotherapy

Outcome Measures

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale [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)

Secondary Outcome Measures

Beck Depression Inventory [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) [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) [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) [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) [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) [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) [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) [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) [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Between the ages of 18 to 64 years old.
Able to provide informed consent.
Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview.
Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression).
Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview.
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:

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.
Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.
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.
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.
Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
A history of allergic or other adverse reaction to ketamine (or its excipients).
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).
QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded.
Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
Subjects with kidney or liver impairment.