Psilocybin and Affective Function in Chronic Lower Back Pain Depression
Johns Hopkins University
Summary
This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.
Description
This study will investigate the effects of a single experimental psilocybin (25 mg fixed dose) administration compared to a dose of methylphenidate (40 mg fixed dose). Assessments will be conducted during screening visits, before and after the drug session, at follow up visits up to 1-month after the drug session, as well as periodically throughout study participation via a multi-time-per-day survey application. Forty participants will complete all study visits including follow-up visits. Primary objectives: 1. Investigate the feasibility, safety, and acceptability of psilocybin for CLBP+D 2…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 21 to 80 years old * Have given written informed consent * Report low back pain as ongoing problem ≥ 3 months and any low back pain on at least half of the days over the past 6 months (consistent with NIH Consensus Recommendations for defining CLBP; other chronic pain problems can be present, but CLBP must be reported as primary) * Report at least moderate depression symptoms Grid-Hamilton Depression Rating Scale (GRID-HAMD) ≥ 17 * Fluent in English * At least high school level of education * Agree to abstain from any psychoactive drugs on the day prior to and the day of…
Interventions
- DrugPsilocybin
Drug administration under supportive conditions
- DrugMethylphenidate
Drug administration under supportive conditions
Location
- Johns Hopkins University School of MedicineBaltimore, Maryland