A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue
Status:
Recruiting
Trial end date:
2023-12-29
Target enrollment:
Participant gender:
Summary
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.