KAP for Depression in Abstinent Opioid Users | NCT05193318

NCT05193318

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Beck Depression Inventory	Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)	Change from baseline measured at week 1-9, 10, 12, and 16
Visual Analog Scale (VAS)

Eligibility Module

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:

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.

Name	Affiliation	Role
Eric T Dobson, MD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina Centerspace		Charleston	South Carolina	29403	United States

Arm/Group Information

ID	Title	Description
FG000	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. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 18, 2022	Mar 13, 2024	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Dec 7, 2021	Mar 13, 2024	ICF_001.pdf

ID	Term
D009293	Opioid-Related Disorders
D003865	Depressive Disorder, Major

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders