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Ketamine for Opioid Use Disorder and Depression

Phase 1
Waitlist Available
Led By Annabelle Belcher, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18 to 65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial seeks to evaluate whether ketamine can improve outcomes for people with opioid use disorder who are also struggling with depression.

Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder and depression, who are new to methadone maintenance treatment. Participants must have moderate-to-severe opioid addiction, score at least 10 on the PHQ-9 depression scale, and not have a history of ketamine or PCP dependence. Exclusions include heart issues, high blood pressure, significant lab abnormalities, pregnancy, serious mental illness including psychosis or bipolar disorder.Check my eligibility
What is being tested?
The study tests if ketamine can help people with opioid addiction and depression while they're getting methadone treatment. It looks at how well patients accept this approach and its initial effectiveness in improving their adherence to methadone therapy.See study design
What are the potential side effects?
Ketamine may cause side effects like increased blood pressure, disorientation or confusion shortly after administration, potential bladder problems with long-term use, mood swings or changes in mental state.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility: Study Recruitment
Feasibility: Study Retention
Patient Acceptability: Acceptability of the Intervention Measure (AIM)
+1 more
Secondary outcome measures
Changes in Depressive Symptoms
Changes in Psychiatric Diagnosis of Depression
Patient Treatment Retention
Other outcome measures
Acceptability of the Intervention (AIM)
Clinician Administered Dissociative Symptom Scale (CADSS-6)
Craving Assessment
+8 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Trial Design

1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~910

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
684 Previous Clinical Trials
373,104 Total Patients Enrolled
Annabelle Belcher, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Ketamine Hydrochloride Clinical Trial Eligibility Overview. Trial Name: NCT05051449 — Phase 1
Opioid Use Disorder Research Study Groups: Ketamine
Opioid Use Disorder Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05051449 — Phase 1
Ketamine Hydrochloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051449 — Phase 1
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05051449 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol available to participants at present?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking participants as of October 7th 2022 - the date that it was last updated. The initial posting on April 4th 2022 highlighted 6 enrollees needed at a single institution."

Answered by AI

Is Ketamine Hydrochloride a viable option for individuals with no long-term risks?

"The safety of Ketamine Hydrochloride is rated as 2 since there has been some evidence to suggest it is safe but no data demonstrating its efficacy."

Answered by AI

Is this clinical investigation open to elderly participants?

"As per the eligibility requirements, only individuals aged 18 or older but no more than 65 can enroll in this clinical trial."

Answered by AI

How many research subjects are engaged in this investigation?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively searching for participants to join their research endeavour. This project was initially posted online on April 4th 2022 and has been freshly updated as of October 7th 2022. The team are seeking 6 volunteers at one facility in particular."

Answered by AI

Do I qualify to partake in this experiment?

"This clinical trial is accepting 6 individuals, aged 18 to 65 years old, diagnosed with melancholia. Besides meeting the age criteria, potential participants must also meet certain prerequisites including: a history of illicit opioid use according to National Health Service (NHS) prescreening; fulfilment of DSM-5/ICD-10 criteria for moderate-to-severe opioid or heroin use disorder; acceptance into methadone maintenance care for treatment of opioid or heroin use disorder; 10 points on the PHQ-9 scale at screening stage and no prior sustained experience/dependence on ketamine as per responses in the respective questionnaire."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Pennsylvania
Other
Maryland
What site did they apply to?
University of Maryland Baltimore
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

Always wanted to help make advances into medical treatments. I Have Tried 3 other medications that didn't work and now I'm hoping can finally get help to treat my medical diagnosis.
PatientReceived 2+ prior treatments
I've tried everything Wellbutrin, Lexapro, with no affect at all even after 6 weeks of use, I ve heard about ketamine and wanted to try it , but most always they wanted $$$, that I don't have. Please give me a chance, so I can hopefully experience what been without depression feels like.
PatientReceived 1 prior treatment
~2 spots leftby Mar 2025