All > Opioid Dependence

Ketamine Hydrochloride for Opioid Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Maryland Baltimore, Baltimore, MDOpioid Use Disorder+1 MoreKetamine Hydrochloride - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

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

Eligible Conditions
  • Opioid Use Disorder
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Pramipexole
1
Remifentanil Hydrochloride
1
Ketamine Hydrochloride

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: One year

One monrh
Subjective Opioid Withdrawal Scale (SOWS)
One month
Acceptability of the Intervention (AIM)
Changes in Depressive Symptoms
Changes in Psychiatric Diagnosis of Depression
Craving Assessment
Generalized Anxiety Disorder 7-item scale (GAD-7)
Objective Opioid Withdrawal Scale (OOWS)
Patient Acceptability: AIM
Patient Acceptability: Acceptability of the Intervention Measure (AIM)
Patient Acceptability: Engagement
Pittsburgh Sleep Quality Index (PSQI)
Self-report of illicit substance use
The Short Inventory of Problems-Revised (SIP-R)
One year
Feasibility: Study Recruitment
Feasibility: Study Retention
Three months
Patient Treatment Retention
Two weeks
Clinician Administered Dissociative Symptom Scale (CADSS-6)
Drug Effects Questionnaire-5 (DEQ-5)
Modified Aldrete

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Pramipexole
2
Remifentanil Hydrochloride
2
Ketamine Hydrochloride

Side Effects for

Ketamine
1%Lightheadedness with low blood pressure
1%PTSD
1%Pump Malfunction
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03156504) in the Ketamine ARM group. Side effects include: Lightheadedness with low blood pressure with 1%, PTSD with 1%, Pump Malfunction with 1%.

Trial Design

1 Treatment Group

Ketamine
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Ketamine Hydrochloride · No Placebo Group · Phase 2

Ketamine
Drug
Experimental Group · 1 Intervention: Ketamine Hydrochloride · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
618 Previous Clinical Trials
356,677 Total Patients Enrolled
Annabelle Belcher, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a serious addiction to opioids or heroin, as diagnosed by medical professionals.
You use illegal drugs like opioids regularly.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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