Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

Overseen By Courtney Vecera

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Unstable medical condition, Psychotic disorder, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a nasal spray of ketamine to help people with severe depression or bipolar disorder who are at risk of suicide. This treatment is being tested because current options are not effective enough for these patients. Ketamine is expected to work quickly to improve mood and reduce suicidal thoughts. Originally used as an anesthetic, ketamine has shown rapid antidepressant effects and is being explored for its potential to quickly reduce suicidal thoughts in these patients.

Will I have to stop taking my current medications?

Yes, you must not take any medication in the 24 hours before participating in the trial.

What data supports the effectiveness of the drug intranasal ketamine?

Research shows that intranasal ketamine can effectively reduce pain in emergency settings and for cancer-related pain, and it has also been used to help with depression. This suggests it may be a promising option for managing pain and mood disorders. ^{1 2 3 4 5}

Is intranasal ketamine safe for use in humans?

Intranasal ketamine has been used safely as an anesthetic for over 50 years and recent studies suggest it is generally safe for treating conditions like depression and pain, with no significant adverse effects reported in these cases. ^{1 2 3 4 6}

How is intranasal ketamine different from other drugs for pain management?

Intranasal ketamine is unique because it is administered through the nose, providing a non-invasive and quick-acting option for pain relief. Unlike traditional pain medications that are often taken orally or intravenously, this method can be more convenient and less resource-intensive, especially in emergency settings. ^{1 2 4 5 7}

Research Team

Rodrigo Machado-Vieira, MD, PhD, MSc

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

The patient is able to provide written informed consent.

DSM-IV-TR criteria for alcohol abuse include continued drinking in spite of problems caused by alcohol, such as drinking in situations where it is inappropriate or having to drink more and more to get the same effects

The person has a high score on the SSI scale (first five items) and a score of 4 or 5 on the Columbia scale.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intranasal dose of ketamine or placebo

1 day

1 visit (inpatient)

Follow-up

Participants are monitored for rapid and sustained antisuicidal and antidepressant effects

1 week

2 visits (in-person)

Treatment Details

Interventions

• Intranasal ketamine
• Placebo

Participant Groups

Group I: Intranasal ketamine Experimental Treatment 1 Intervention

Intranasal ketamine

Group II: Placebo Placebo Group 1 Intervention

non-active placebo

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

This study is investigating the safety and feasibility of intranasal ketamine for treating uncontrolled cancer pain, with initial results from 7 subjects indicating potential for effective pain management without the harmful side effects associated with opioids.

If successful, intranasal ketamine could offer a non-opioid alternative for cancer pain relief, improving patients' quality of life while avoiding issues like respiratory depression and constipation that are common with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer-Related Pain: Protocol of a Phase I/II Clinical Trial. Shteamer, JW., Harvey, RD., Spektor, B., et al.[2020]

In a study using rat models of traumatic brain injury caused by maxillofacial impact, ketamine treatment significantly improved recovery time, with treated rats recovering about 2 days faster than the control group.

The results suggest that ketamine may be an effective intervention for enhancing recovery following traumatic brain injuries, indicating its potential therapeutic role in similar human injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Animal experiment of the ketamine effects on traumatic brain injury resulting from impact maxillofacial injury]. Zhang, C., Li, H., Liao, W., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prehospital Analgesia With Intranasal Ketamine (PAIN-K): A Randomized Double-Blind Trial in Adults. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of intranasal ketamine for acute pain management in adults: a systematic review and meta-analysis. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer-Related Pain: Protocol of a Phase I/II Clinical Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Compounded intranasal racemic ketamine for major depressive disorder: A case report. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Analgesic Effects of Intranasal Ketamine in Rat Models of Facial Pain. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A dose-escalation clinical trial of intranasal ketamine for uncontrolled cancer-related pain. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Animal experiment of the ketamine effects on traumatic brain injury resulting from impact maxillofacial injury]. [2013]