Outpatient Study of Ketamine Treatment for Phantom Limb Pain Over Six Months with Minimum One-Week Remission Between Sessions

What this Trial Is About

Researchers are evaluating the use of ketamine to treat phantom limb pain PLP, a severe and often difficult-to-manage pain experienced by over half of amputees. This trial explores ketamines potential as an alternative to opioids and other pain medications, which often have limited effect. The study is sponsored by The Ketamine Research Foundation and aims to clarify ketamines role in managing this complex pain condition through careful assessment of pain and emotional impact. Participants will receive up to 16 intramuscular ketamine sessions over six months, with dosage adjusted during an initial escalation phase up to a maximum of 120 mg. The timing between sessions depends on the length of symptom remission, which must last at least seven days to continue treatment. Support and integration therapy, similar to ketamine-assisted psychotherapy, will accompany the medication sessions. The study includes a follow-up period to monitor sustained effects and responses. During the trial, participants will undergo regular assessments using tools such as the McGill Pain Questionnaire over six months and a 12-month follow-up. Laboratory tests for liver and kidney function will be done at three and six months. Participants will keep daily diaries to track medication use and symptoms, with careful monitoring of any medication interactions or side effects. The total study participation may last over a year, including follow-up to observe long-term outcomes and safety.

Clinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved.