Ketamine for Fatigue

Overseen By Alexander L Ross, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Nursing Research (NINR)

Must not be taking: Antidepressants, Antipsychotics, Anxiolytics, Mood stabilizers

Disqualifiers: Unstable disease, Psychiatric disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Many people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people. Researchers hope that ketamine, compared to a drug called midazolam, can reduce fatigue in people with illnesses. Objective: To test whether ketamine reduces fatigue in cancer survivors and people with chronic illness. Eligibility: Adults between the ages of 18 and 70 who have fatigue and are cancer survivors or have been diagnosed with a chronic illness such as chronic fatigue syndrome and lupus. Design: Participants will be screened with a physical exam, medical history, blood and urine tests, questions about their fatigue, and breathalyzer test. During phase 1, participants will complete rating their fatigue using questionnaires. They will be provided thinking, memory, and motivation tests. They will also take a handgrip test. For this study, the participant will have an IV, which a needle guides a thin plastic tube (intravenous or IV line) into an arm in their vein. An IV will be required for two of the visits. They will get a single dose of either ketamine or midazolam through an IV line over 40 minutes. Participants must be accompanied by a responsible friend/family/colleague to take them home after getting the study drug. Participants will have follow-up visits where they repeat the above tests. They will also have follow-up phone calls. Phase 2 is the same as phase 1, but participants get the other study drug. The study lasts 1 month. Each phase lasts 2 weeks. Participants will have 6-8 total NIH visits. For the whole study, they will wear a device on their wrists that records physical activity. Drug side effects can include vivid dreams, seeing colors, perceiving time as moving slower or faster than normal, dizziness, headache, restlessness, nausea, or vomiting, among others.

Research Team

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

Principal Investigator

National Institute of Nursing Research (NINR)

Eligibility Criteria

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.

Inclusion Criteria

Intensity greater than or equal to 50 mm using fatigue VAS (on a 0-100 mm horizontal fatigue scale)

I cannot have children due to menopause, surgery, or a congenital condition.

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

Exclusion Criteria

My illness is getting worse and makes me very tired.

Current substance use disorder within the last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5) or positive urine toxicology results at enrollment

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment Phase 1

Participants receive a single dose of either ketamine or midazolam through an IV line over 40 minutes, followed by assessments including fatigue questionnaires, cognitive tests, and physical activity monitoring.

2 weeks

3-4 visits (in-person), 1-2 phone calls

Washout

A two-week washout period where no active treatment is administered to allow the effects of the first drug to dissipate.

2 weeks

Treatment Phase 2

Participants receive the alternate study drug (either ketamine or midazolam) through an IV line over 40 minutes, followed by similar assessments as in Phase 1.

2 weeks

3-4 visits (in-person), 1-2 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up visits and phone calls.

1 week

1-2 visits (in-person), 1-2 phone calls

Treatment Details

Interventions

• Ketamine
• Midazolam
• Midazolam (placebo)

Trial Overview 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.

Participant Groups

Group I: Ketamine then midazolam administration Experimental Treatment 2 Interventions

Participants receive ketamine 0.5 mg/kg intravenous infusion over 40 minutes followed by a two week washout period then receive midazolam 0.045 mg/kg intravenous infusion over 40 minutes followed by two weeks of observation.

Group II: Midazolam then ketamine administration Active Control 2 Interventions

Participants receive midazolam 0.045 mg/kg intravenous infusion over 40 minutes followed by a two week washout period then receive ketamine 0.5 mg/kg intravenous infusion over 40 minutes followed by two weeks of observation.

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

National Institute of Nursing Research (NINR)

Lead Sponsor

Trials

623

Recruited

10,400,000+