Status:
TERMINATED
KAP for Depression in Abstinent Opioid Users
Lead Sponsor:
Medical University of South Carolina
Conditions:
Opioid Use Disorder, Severe, in Sustained Remission
Opioid Use Disorder, Severe, in Early Remission
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05193318
Start Date
January 13 2022
End Date
March 20 2023
Last Update
May 6 2024
Active Locations (1)
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1
Medical University of South Carolina Centerspace
Charleston, South Carolina, United States, 29403