KAP for Depression in Abstinent Opioid Users

NCT05193318 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: Pro00115696
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale

  Montgomery Asberg Depression Rating Scale (MADRS). 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. Lower scores are better (less depression).

  Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

Secondary Outcomes (7)

• Beck Depression Inventory

  Change from baseline measured at week 1-9, 10, 12, and 16

• Visual Analog Scale (VAS)

  Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

• Generalized Anxiety Disorder-7 (GAD-7)

  Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16.

• Mystical Experience Questionnaire (MEQ)

  Measured at week 1-8

• Brief Pain Inventory (BPI)

  Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

Study Arms (1)

Ketamine-assisted psychotherapy

EXPERIMENTAL

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

Interventions

Ketamine-assisted psychotherapy DRUG

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.

Ketamine-assisted psychotherapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Centerspace

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Results Point of Contact

• Title: Eric Dobson, MD (principal nvestigator)
• Organization: Metrohealth Hospital System (formerly employee of Medical University of South Carolina)

edobson@metrohealth.org

513-504-2091

Study Officials

• Eric T Dobson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 14, 2022
• Study Start: January 13, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-04

Locations

US (1)