TerminatedNCT05193318KReDOUpdated May 6, 2024Results posted

KAP for Depression in Abstinent Opioid Users

A Phase 2 interventional study of Ketamine-assisted psychotherapy in Opioid Use Disorder, Severe, in Sustained Remission, Opioid Use Disorder, Severe, in Early Remission and Major Depressive Disorder, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment

Why this study was terminated

Primary Investigator leaving institution

Phase: Phase 2
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 18 Years to 64 Years
Sex: All

Study 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 studied

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

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In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 5 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

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Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

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.
Drug: Ketamine-assisted psychotherapy

Interventions

DrugKetamine-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.

What researchers measure

Primary outcomes

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

Secondary outcomes

Beck Depression Inventory
Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
Time frame: Change from baseline measured at week 1-9, 10, 12, and 16
Visual Analog Scale (VAS)
Measure of subjective level of opioid craving; maximum score of 100 and minimum score of 0 with higher scores meaning worse outcome (more cravings)
Time frame: 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)
Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)
Time frame: 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)
Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense perceptual experience. Total scores are presented as an average (mean) of the 30 item scale, each of which are rated out of 5. Scale is ordered as follows (in reference to magnitude of various perceptual experiences during acute ketamine session): 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4).
Time frame: Measured at week 1-8
Brief Pain Inventory (BPI)
Measure of pain. Sub-scale 3 specifically was reported for this outcome. Subjects were asked: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours"; maximum score of 10 and minimum of 0 with higher scores indicating worse outcome (more pain) and a score of 0 indicating best outcome (no pain).
Time frame: Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
PTSD Checklist (PCL-5; PTSD Checklist 5)
Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)
Time frame: Measured at week 1-9, 10, 12, and 16
Timeline Follow-back (TLFB)
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)
Time frame: Measured at week 1-9, 10, 12, and 16

Results

Posted May 6, 2024

Participant flow

Intended total recruitment was 10 participants, however study was concluded after a total of 5 participants were recruited.

Acute Intervention (Weeks 1-9 of Study)

Participant flow — Acute Intervention (Weeks 1-9 of Study)
Milestone	Ketamine-assisted Psychotherapy
Started	5
Completed	4
Not completed	1
Withdrew: Physician decision	1

Follow-up Phase (Through Week 16)

Participant flow — Follow-up Phase (Through Week 16)
Milestone	Ketamine-assisted Psychotherapy
Started	4
Completed	3
Not completed	1
Withdrew: Lost to follow-up	1

Outcome measures

PrimaryMontgomery 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).

Time frame:: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Reported as:: Mean · score on a scale

Montgomery Asberg Depression Rating Scale
score on a scale	Ketamine-assisted Psychotherapy
Week 1	-1.75 ± 3.5
Week 2	-3.25 ± 3.0
Week 3	-7.25 ± 7.27
Week 4	-11.75 ± 7.37
Week 5	-9 ± 6.98
Week 6	-18.3 ± 6.18
Week 7	-19 ± 4.83
Week 8	-20 ± 6.32
Week 9	-15.5 ± 7.55
Week 10	-10.7 ± 12.7
Week 12	-8.33 ± 18.15
Week 16	-10.67 ± 15.82

SecondaryBeck Depression Inventory

Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)

Time frame:: Change from baseline measured at week 1-9, 10, 12, and 16
Reported as:: Mean · score on a scale

Beck Depression Inventory
score on a scale	Ketamine-assisted Psychotherapy
Week 1	-1.6 ± 1.7
Week 2	-6.4 ± 5.0
Week 3	-8.8 ± 11.3
Week 4	-11.8 ± 9.8
Week 5	-9 ± 12.2
Week 6	-13 ± 9.1
Week 7	-15.5 ± 8.5
Week 8	-18 ± 9.6
Week 9	-17.3 ± 10.3
Week 10	-15.3 ± 9.5
Week 12	-13.7 ± 16.3
Week 16	-16.7 ± 9.9

SecondaryVisual Analog Scale (VAS)

Measure of subjective level of opioid craving; maximum score of 100 and minimum score of 0 with higher scores meaning worse outcome (more cravings)

Time frame:: Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Reported as:: Mean · score on a scale

Visual Analog Scale (VAS)
score on a scale	Ketamine-assisted Psychotherapy
Week 1	5 ± 17.97
Week 2	5 ± 37.3
Week 3	9.25 ± 43.14
Week 4	4.75 ± 47.77
Week 5	10 ± 49.48
Week 6	-1.25 ± 38.43
Week 7	-1.75 ± 33.09
Week 8	1.25 ± 36.55
Week 9	-6 ± 38.17
Week 10	-2 ± 55.03
Week 12	-4.33 ± 54.63
Week 16	-11 ± 42.58

SecondaryGeneralized Anxiety Disorder-7 (GAD-7)

Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)

Time frame:: Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16.
Reported as:: Mean · score on a scale

Generalized Anxiety Disorder-7 (GAD-7)
score on a scale	Ketamine-assisted Psychotherapy
Week 1	-2.2 ± 3.35
Week 2	-4.2 ± 3.11
Week 3	-6.75 ± 4.72
Week 4	-6.5 ± 3.11
Week 5	-6.25 ± 3.59
Week 6	-8.75 ± 4.43
Week 7	-7 ± 5.03
Week 8	-9 ± 3.37
Week 9	-8.75 ± 4.92
Week 10	-6.33 ± 4.16
Week 12	-8.33 ± 6.11
Week 16	-9 ± 5

SecondaryMystical Experience Questionnaire (MEQ)

Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense perceptual experience. Total scores are presented as an average (mean) of the 30 item scale, each of which are rated out of 5. Scale is ordered as follows (in reference to magnitude of various perceptual experiences during acute ketamine session): 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4).

Time frame:: Measured at week 1-8
Reported as:: Mean · score on a scale

Mystical Experience Questionnaire (MEQ)
score on a scale	Ketamine-assisted Psychotherapy
Week 1	2.96 ± 1.20
Week 2	2.32 ± 1.37
Week 3	3.55 ± 0.81
Week 4	3.54 ± 0.81
Week 5	3.88 ± 0.87
Week 6	3.25 ± 0.84
Week 7	4.28 ± 0.55
Week 8	3.9 ± 0.78

SecondaryBrief Pain Inventory (BPI)

Measure of pain. Sub-scale 3 specifically was reported for this outcome. Subjects were asked: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours"; maximum score of 10 and minimum of 0 with higher scores indicating worse outcome (more pain) and a score of 0 indicating best outcome (no pain).

Time frame:: Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Reported as:: Mean · score on a scale

Brief Pain Inventory (BPI)
score on a scale	Ketamine-assisted Psychotherapy
Baseline	1.4 ± 1.95
Week 1	1.6 ± 2.30
Week 2	1.2 ± 2.17
Week 3	0.33 ± 0.58
Week 4	0 ± 0
Week 5	0 ± 0
Week 6	0 ± 0
Week 7	0 ± 0
Week 8	0 ± 0
Week 9	0 ± 0
Week 10	0 ± 0
Week 12	0 ± 0
Week 16	0 ± 0

SecondaryPTSD Checklist (PCL-5; PTSD Checklist 5)

Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)

Time frame:: Measured at week 1-9, 10, 12, and 16
Reported as:: Mean · score on a scale

PTSD Checklist (PCL-5; PTSD Checklist 5)
score on a scale	Ketamine-assisted Psychotherapy
Week 1	64 ± 7.55
Week 2	54 ± 17.08
Week 3	42.33 ± 19.09
Week 4	45.33 ± 18.04
Week 5	44 ± 21.21
Week 6	32.33 ± 18.93
Week 7	37 ± 31.11
Week 8	36 ± 19.80
Week 9	37 ± 25.46
Week 10	40.5 ± 28.99
Week 12	39 ± 33.94
Week 16	38.5 ± 27.58

SecondaryTimeline Follow-back (TLFB)

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)

Time frame:: Measured at week 1-9, 10, 12, and 16
Reported as:: Mean · days per week

Timeline Follow-back (TLFB)
days per week	Ketamine-assisted Psychotherapy
Week 1	0.6 ± 1.34
Week 2	0 ± 0
Week 3	0 ± 0
Week 4	0 ± 0
Week 5	1 ± 2
Week 6	0.35 ± 0.7
Week 7	0 ± 0
Week 8	0 ± 0
Week 9	0 ± 0
Week 10	0 ± 0
Week 12	0 ± 0
Week 16	0 ± 0

Adverse events

Collected over 16 weeks after initiation of acute intervention. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ketamine-assisted Psychotherapy	0/5 (0%)	0/5 (0%)	3/5 (60%)

Most frequent other events

Most frequent other events
Event	Ketamine-assisted Psychotherapy
NauseaGastrointestinal disorders	3/5

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ketamine-assisted Psychotherapy
Mean	31.2 ± 8.1

Sex: Female, Male
Sex: Female, Male(Participants)	Ketamine-assisted Psychotherapy
Female	4
Male	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ketamine-assisted Psychotherapy
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	4
More than one race	1
Unknown or Not Reported	0

Sexual orientation
Sexual orientation(Participants)	Ketamine-assisted Psychotherapy
Heterosexual	3
Homosexual	1
Bisexual	1

MADRS baseline
MADRS baseline(units on a scale)	Ketamine-assisted Psychotherapy
Mean	34.0 ± 6.0

BDI Baseline
BDI Baseline(units on a scale)	Ketamine-assisted Psychotherapy
Mean	42.8 ± 7.7

GAD-7 Baseline
GAD-7 Baseline(units on a scale)	Ketamine-assisted Psychotherapy
Mean	18.4 ± 1.8

Study locations

1 site

Medical University of South Carolina Centerspace
Charleston, South Carolina 29403, United States

References and documents

Study documents

Protocol and statistical analysis plan · Aug 18, 2022
Informed consent form · Dec 7, 2021

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05193318
Lead sponsor: Medical University of South Carolina
Responsible party: Eric Dobson (Principal Investigator, Medical University of South Carolina) — Principal investigator
First posted: Jan 14, 2022
Start date: Jan 13, 2022
Primary completion: Mar 20, 2023
Completion: Mar 20, 2023
Results posted: May 6, 2024
Last update: May 6, 2024

Study contacts

Eric T Dobson, MD

principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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