Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial
ConditionChronic Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
This is a Health Canada regulated internal pilot study designed to assess the feasibility, tolerability, and preliminary efficacy of 3, 4-methylenedioxymethamphetamine hydrochloride capsules-AT for chronic neuropathic pain to inform a larger, fully powered multi-center study. This is an interventional, randomized, 2-arm parallel, blinded (Treating and dosing physician, Patient Outcome assessor and psychotherapist).
The total study duration is 2 years.
Participants will receive preparatory psychotherapy session during week 2 and week 4 followed by a combined single dosing session with psychotherapy during week 6. Integrative psychotherapy will follow at weeks 6, 8, 12, and 16.
Follow up for primary clinical endpoint at week 16; final follow up for secondary clinical endpoint at 16-weeks.
Participants will be asked to complete adjunctive home psychotherapy in the form of online modules. Data collected will be entered in electronic case report form (REDCap Academic).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consenting adults 18 years and older.
Diagnosis of chronic neuropathic pain (greater than 3 months in duration) by a clinician with specialized training in chronic pain, confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs questionnaire.
Suffering from moderate-to-severe pain as defined by
Baseline Patient Reported Outcomes Measurement System - Pain Interference (PROMIS-PI) score of greater than or equal to 60
Disqualifiers
Past or current history of a psychotic disorder, mania, hypomania, bipolarity, current suicidal ideation, stimulant use disorder (i.e., cocaine, amphetamine, methamphetamine, MDMA, methylphenidate (Ritalin), etc , and any other substance use disorder within the past 12 months assessed by history and confirmed the Mini-International Neuropsychiatric Interview [MINI]. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma related disorders, other personality disorders. etc.) will not be excluded
Participants with a history of suicide attempts are not excluded unless a significant risk of suicidal behavior is present at the time of screening as determined by the CRSS (Columbia suicide rating scale)
History of prior MDMA use (excluded to maintain blinding integrity)
Long QT syndrome, measured by an ECG with a QTc more than 450 ms for males, and 470 ms for females.
Trial design
Design model
Parallel
Treatments tested in this trial
3,4-Methylenedioxymethamphetamine
DrugTreatment arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg)
Methylphenidate
DrugPlacebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: 3,4-MethylenedioxymethamphetamineActive comparator 1 intervention
Group B: MethylphenidatePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome of this pilot trial is to determine feasibility of a large-scale, multi-center trial.
Average Monthly recruitment of \>1 participant per center means that the full trial should meet recruitment requirements within 12 months.
Time frame
16 weeks2
Secondary feasibility outcome
Data completion rate (of primary clinical outcome)≥ 80%
Time frame
16 weeks3
Participant Retention
Retention of ≥80% of participants at the reported primary outcome point of 16 weeks after the experimental session should minimize attrition bias in the definitive trial's primary outcome data (e.g. withdrawal due to side-effects)
Time frame
16 weeks4
Blinding
Blinding Integrity (≤80% of participants in both arms correctly guess their treatment allocation (Note: 50% of participants would be expected to correctly guess treatment allocation due to chance alone)
Time frame
16 weeksSecondary outcomes
1
The Patient-Reported Outcomes Measurement Information System (PROMIS) pain Intensity, Pain Interference and Physical Function Scale
In the past 7 days patients to rate their pain on average- 0 scale-indicates No pain and 10 scale- indicates Worst imaginable pain
Time frame
Week 1, Week 7, Week 11 and Week 162
Patient Health Questionnaire (PHQ-9)
Over the last 2 weeks how often the patient has been bothered by daily activities on a scale of 0 to 3. 0 (Not at all) and 3 (Nearly every day)
Time frame
Week 1, Week 7, Week 11 and Week 163
Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire
Over the last 2 weeks, how often patients have been bothered by anxiety on a scale of 0 to 3. 0 equals Not at all and 3 equals Nearly every day
Time frame
Week 1, Week 7, Week 11 and Week 164
The Post traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual for Mental Disorder-5 (PCL-5)
Over the past month, how patients were bothered by internal and external feelings like stress, negativity etc. This is measured on a scale of 0 (Not at all) to 4 (Extremely)
Time frame
Week 1, Week 7, Week 11 and Week 16Sponsors and contacts
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Source ClinicalTrials.gov