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NMDA receptor antagonist

Ketamine for Fatigue

Phase 1 & 2

Waitlist Available

Led By Leorey N Saligan, C.R.N.P.

Research Sponsored by National Institute of Nursing Research (NINR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For individuals of childbearing potential; must use at least one of the following highly effective birth control methods for the duration of the study: Prescribed hormonal oral contraceptives, vaginal ring, or transdermal patch. Intrauterine device (IUD). Intrauterine hormone-releasing system (IUS). Depot/implantable hormone (e.g., Depo-provera , Implanon). Bilateral tubal occlusion/ligation.

Have chronic, persistent fatigue for at least 6 months

Must not have

Has a diagnosis of progressive or unstable disease to any body system causing clinically significant fatigue

Total body irradiation or cranial irradiation for cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

Summary

This trial will test whether ketamine reduces fatigue in cancer survivors and people with chronic illness. Participants will be screened, then given either ketamine or midazolam through an IV and monitored for side effects. The study lasts 1 month and participants will have 6-8 NIH visits.

Who is the study for?

Adults aged 18-70 with chronic fatigue due to cancer survival or illnesses like lupus, who've had persistent fatigue for over six months. They must be able to consent and have someone accompany them post-drug infusion. Women of childbearing age should use effective birth control.

What is being tested?

The trial is testing if ketamine can reduce fatigue compared to midazolam (placebo) in cancer survivors and those with chronic illness. Participants will receive one drug first, then the other, while undergoing tests measuring their fatigue levels.

What are the potential side effects?

Possible side effects include vivid dreams, altered perception of time and colors, dizziness, headache, restlessness, nausea or vomiting. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using a reliable birth control method during the study.

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I have been feeling very tired for at least 6 months.

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I often feel very tired, more than halfway on a scale.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My illness is getting worse and makes me very tired.

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I have received whole-body or brain radiation for cancer.

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I have been diagnosed with acute narrow-angle glaucoma.

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My thyroid is not working properly, as shown by TSH levels.

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I have been diagnosed with PTSD or traumatic brain injury.

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I have a health condition that affects my ability to move.

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I have kidney disease, but it's stable and my filtration rate is over 45.

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My blood pressure is not well controlled.

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I have a sleep condition that has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after a dose of ketamine or active placebo at multiple time points (at +40 min, at +80 min, at +120 min, at +230 min, at 24 hours, at 7 days, and at 14 days). for reporting.