Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre for Addiction and Mental Health
About this trial
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.
Eligibility criteria
Qualifiers
Adults 18 to 65 years old;
Are outpatients;
Must be deemed to have capacity to provide informed consent;
Must sign and date the informed consent form;
Disqualifiers
Pregnant as assessed by a urine pregnancy test at Screening (V1) or individuals that intend to become pregnant during the study or are breastfeeding;
Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
Have a DSM-5 diagnosis of substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;
Trial design
Treatments tested in this trial
- Psilocybin 25 mg
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov