Opioid Use Disorder, Severe, in Sustained RemissionPhase 2KReDONCT05193318

KAP for Depression in Abstinent Opioid Users

A Phase 2 study testing Ketamine-assisted psychotherapy in people with Opioid Use Disorder, Severe, in Sustained Remission and Opioid Use Disorder, Severe, in Early Remission, run by Medical University of South Carolina at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Opioid Use Disorder, Severe, in Sustained Remission, Opioid Use Disorder, Severe, in Early Remission, Major Depressive Disorder
What is being tested?: Ketamine-assisted psychotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 13 Jan 2022to 20 Mar 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

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
Being tested: Ketamine-assisted psychotherapy
Medical subject headings: Opioid-Related Disorders, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketamine-assisted psychotherapyDrug
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.

Study groups in NCT05193318
Study group	Role	What they receive
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. Receives: Drug: Ketamine-assisted psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Measured at week 1-9, 10, 12, and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202220 Mar 2023

First posted14 Jan 2022
Study start13 Jan 2022
Primary completion20 Mar 2023
Study completion20 Mar 2023

Why it stopped: Primary Investigator leaving institution

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid Use Disorder, Severe, in Sustained RemissionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT05193318
Sponsor's protocol ID: Pro00115696
Acronym: KReDO
Status last verified: Apr 2024
First submitted: 14 Dec 2021
Last updated: 6 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
ClinicalTrials.gov ID: NCT05193318
Acronym / sponsor ID: KReDO / Pro00115696
Conditions: Opioid Use Disorder, Severe, in Sustained Remission, Opioid Use Disorder, Severe, in Early Remission, Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Primary Investigator leaving institution
Enrolment: 5 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 13 Jan 2022 (actual)
Primary completion: 20 Mar 2023 (actual)
Study completion: 20 Mar 2023 (actual)
First posted: 14 Jan 2022 (actual)
Results: Posted 6 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ketamine-assisted psychotherapy	Experimental	Drug: Ketamine-assisted psychotherapySubjects 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketamine-assisted psychotherapySubjects 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

Primary outcome

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

7 secondary outcomes

Beck Depression Inventory
Time frame: Change from baseline measured at week 1-9, 10, 12, and 16
Visual Analog Scale (VAS)
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)
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)
Time frame: Measured at week 1-8
Brief Pain Inventory (BPI)
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)
Time frame: Measured at week 1-9, 10, 12, and 16
Timeline Follow-back (TLFB)
Time frame: Measured at week 1-9, 10, 12, and 16

Results and safety

Results posted to the registry on 6 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketamine-assisted Psychotherapy	5	4

Primary outcome: Montgomery Asberg Depression Rating Scale

Time frame: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketamine-assisted Psychotherapy n = 5
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)

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks after initiation of acute intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketamine-assisted Psychotherapy	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric T Dobson, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Asberg Depression Rating Scale (time frame: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.