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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Psilocybin 25 mg
DrugThe psilocybin used in this study meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin. The psilocybin will be administered once during the trial in combination with supportive therapy.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Psilocybin (25 mg)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety).
Percentage of participants recruited, enrolled and retained over 24 months. Number of serious adverse events and serious adverse drug reactions associated with psilocybin 25 mg.
Time frame
24 MonthsSecondary outcomes
1
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment.
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that measures depression severity. This measure has 10 items rated from 0-6. The lowest possible score is 0 and highest possible score is 60. Higher composite scores represent a more severe condition/ worse outcomes.
Time frame
Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).Other outcomes
1
Change in Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) from Baseline to 1-week post-treatment.
The Patient Reported Outcomes Measurement Information System-Pain Intensity Scale (PROMIS-PI) is a participant-rated scale that measures intensity of pain experienced by the participant in the past seven days. Presented on a visual analogue scale of 0-10, scores range from 0= no pain to 10=worst imaginable pain. A score of 5 or greater indicates moderate to severe pain intensity.
Time frame
Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).2
Change in Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) from Baseline to 1-week post-treatment.
The Patient Reported Outcomes Measurement Information System- Pain Interference Scale (PROMIS-Interference) is a participant rated scale that aims to identify how much an individual's physical pain has interfered with emotional, social and cognitive domains of living. A T-Score greater than 50 indicates higher pain interference than the general population.
Time frame
Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).Sponsors and contacts
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Source ClinicalTrials.gov