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Home/Research/Placebo/Chronic Pain

Placebo for Chronic Pain

5 papers and 44 clinical trials exploring placebo as a treatment for chronic pain.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo profile
IndicationOver 1.5 billion worldwide.

Chronic Pain

Chronic pain is increasingly recognised as a multifaceted condition that may respond to psychedelic therapies, which are gaining attention in clinical settings for their potential efficacy in pain management. Recent research indicates that compounds such as psilocybin and MDMA are entering clinical trials aimed at exploring their therapeutic effects on chronic pain syndromes.

Full Chronic Pain profile

Academic Research

5 papers
Paywallindividual

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

In a multicentre phase 2b randomised placebo‑controlled trial of 198 adults with moderate to severe GAD, a single dose of MM120 (lysergide D‑tartrate) produced a dose‑dependent reduction in HAM‑A scores at 4 weeks, with 100 µg and 200 µg showing significant improvements versus placebo (least‑squares mean differences −5.0 and −6.0 points, respectively). Adverse events were dose‑related—most commonly visual perceptual changes and nausea—supporting the efficacy and informing dose selection for phase 3 trials.

Published
October 21, 2025
Journal
JAMA
Authors
Robison, R., Barrow, R., Conant, C., Foster, E., Freedman, J. M., Jacobsen, P. L., Karas, S. M., Karlin, D. R., Solomon, T. M., Wernli, M. H., Fava, M. F., Jemisen, J.
Open Accessmeta

Microdosing psychedelics: Current evidence from controlled studies

This systematic review (s=14) compiles double-blind, placebo-controlled studies on microdosing LSD (5-20μg) under laboratory conditions. It reports that acute low doses of LSD affect blood pressure, sleep, neural connectivity, mood, social cognition, and perceptions of pain and time, with noticeable effects at 10-20 μg but not at 5μg. While no serious adverse effects were noted, repeated microdosing did not significantly change mood or cognition.

Published
January 26, 2024
Journal
Biological Psychiatry
Authors
Murphy, R., Muthukumaraswamy, S., De Wit, H.
Open Accessindividual

Nitrous oxide as an adjunctive therapy in major depressive disorder: a randomized controlled double-blind pilot trial

This double-blind placebo-controlled between-subjects study (n=23) tested the antidepressant efficacy of inhaled nitrous oxide (50% N2O|50% O2 versus 100% O2) in patients diagnosed with major depression (MDD). Across multiple treatment sessions administered across a period of 4 weeks, there were significant reductions in depressive symptoms in the acute response to treatment and accumulatively across sessions.

Published
September 1, 2021
Journal
brazilian Journal of Psychiatry
Authors
Guimarães, M. C., Guimarães, T. M., Hallak, J. E., Abrão, J., Machado-de-Sousa, J. P.
Open Accessmeta

Ketamine for the treatment of major depressive disorder and bipolar depression: A review of the literature

This literature review (2017) of randomised, placebo-controlled trials explores the effects of ketamine in treatment-resistant depression (TRD) and bipolar depression (BD). Ketamine reduced symptoms in both and is a promising compound for those who have found other treatments lacking.

Published
January 1, 2017
Journal
Mental Health Clinician
Authors
Grady, S. E., Marsh, T. A., Tenhouse, A., Klein, K.
Open Accessindividual

Effects of serotonin 2A/1A receptor stimulation on social exclusion processing

Using multimodal brain imaging, the study shows that stimulation of serotonin 2A/1A receptors modulates neural processing of social exclusion and associated emotional responses. This implicates the 2A/1A receptor system as a potential pharmacological target for treating sociocognitive deficits in psychiatric disorders.

Published
April 18, 2016
Journal
PNAS
Authors
Preller, K. H., Pokorny, D., Hock, A., Kraehenmann, R., Stämpfli, P., Seifritz, E., Scheidegger, M., Vollenweider, F. X.

Clinical Trials

44 trials
Not yet recruitingPhase II

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

This Phase II, randomised, open-label, parallel trial (n=83) will assess whether prophylactic psilocybin prevents or mitigates chemotherapy-induced peripheral neuropathy (CIPN) in adults receiving adjuvant neurotoxic chemotherapy (taxanes or platinum agents) for breast, colorectal, or head and neck cancers; the primary outcome is the proportion of participants with a ≥25% worsening from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale. Participants are randomised to one of three arms: Arm A receives supervised oral psilocybin 25 mg given as four doses (two pre-chemotherapy doses one week apart on Day 7 and Day 14, then two monthly doses prior to chemotherapy cycles 2 and 3 on Day 42 and Day 70); Arm B receives subperceptual oral psilocybin 1mg administered every other day during a two-week pre-chemotherapy run-in (mailed as 7×1 mg capsules in tamper-evident packaging) with dosing continued prior to the first three cycles (total 21 doses); Arm C receives standard of care with no study drug. The primary analysis compares 25 mg versus pooled control (standard of care plus 1 mg), tested two-sided at α=0.05 with confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) using Hochberg adjustment if significant. Key secondary objectives include rates of chemotherapy dose modifications for neurotoxicity, NCI-CTCAE measures of CIPN, and effects on quality of life and psychosocial outcomes assessed with instruments such as PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 and the Flourishing scale. Eligible participants are adults (≥18 years) with ECOG 0–2, no pre-existing peripheral neuropathy greater than Grade 1, and scheduled for relevant chemotherapy; safety and adverse events are followed through study completion (average 1 year).

Started
May 4, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07227909
RecruitingPhase I

Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

This Phase I, randomised, triple-masked, crossover trial (n=20) will assess the acute analgesic effects of oral MDMA in healthy adults aged 18 to 75 years. It will compare MDMA 25 mg, 75 mg and 125 mg with placebo to evaluate whether MDMA reduces experimentally induced acute nociceptive pain, hyperalgesia and allodynia. Participants will receive the study drug by mouth during a validated electrical stimulation pain model in which repeated small electrical pulses are applied under the skin to produce moderate pain and secondary pain phenomena. The main outcome is periprocedural pain measured with the numerical rating scale, with the highest MDMA dose compared against the lower doses and placebo.

Started
March 9, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07494214
Not yet recruitingPhase I

The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.

This Early Phase I, randomised, double-blinded, placebo-controlled, cross-over trial (n=24) will evaluate the efficacy of intravenous infusions of lidocaine and ketamine in patients suffering from opioid-refractory chronic cancer-related pain. Participants will receive two infusions, spaced one week apart, consisting of lidocaine at 4 mg/kg and ketamine at 0.2 mg/kg, compared to an active placebo of midazolam at 0.02 mg/kg. The primary aim is to determine whether the lidocaine-ketamine regimen provides superior analgesia compared to the placebo. The trial will assess various outcomes, including pain intensity and physical functioning using the Brief Pain Inventory (BPI), emotional functioning via the Beck Depression Inventory (BDI), and overall improvement through the Patient Global Impression of Change (PGIC) scale. Additionally, total opioid consumption will be measured in oral morphine equivalents, and neuropathic pain effects will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Eligible participants are adults aged 18 years or older with moderate to severe cancer-related pain despite optimised analgesic therapy. The study is set to begin in March 2026 and is expected to conclude by August 2027.

Started
March 1, 2026
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT07408193
Not yet recruitingPhase III

Optimal Timing of Ketamine Initiation for SCD Pain

This Phase III, randomised, triple-masked, parallel-group trial (n=90) will evaluate whether a single early oral dose of ketamine 0.5mg/kg (max dose of 35mg) given within 1 hour of presentation reduces the proportion of 6–24-year-olds with sickle cell disease presenting with acute pain who are admitted to hospital. The primary outcome is the percentage of participants admitted from the emergency department or infusion clinic within 6 hours of presentation. Participants are randomised to oral ketamine or placebo; the ketamine study drug is prepared from ketamine hydrochloride injection compounded into an oral solution and administered with taste-masking (either a Listerine strip before and after dosing or mixed with cherry syrup), while placebo is matching sterile water with the same masking. If participants are admitted, they may start open-label intravenous ketamine per clinical need and those who receive inpatient ketamine will be reviewed to assess effects on opioid use and hospital length of stay. Key eligibility includes a diagnosis of sickle cell disease, presentation with pain to ED or infusion clinic, age 6–24 years, and no ketamine allergy or contraindicating history. The study is planned to start in February 2026 with estimated completion in February 2030.

Started
February 1, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07450430
RecruitingPhase II

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

This Phase II, randomised, triple-blinded, parallel trial (n=40) will evaluate the feasibility, tolerability and preliminary efficacy of a single oral dose of MDMA for adults with moderate-to-severe chronic neuropathic pain. The primary purpose is to determine feasibility for a larger multi-centre trial by assessing recruitment, data completion, blinding integrity and drug-related adverse events, while secondary aims include preliminary assessment of pain interference and other clinical outcomes at 16 weeks. Participants are randomised to a treatment arm receiving MDMA 120 mg (3 × 40 mg capsule) orally as a single dose with psychological support and an optional 40 mg supplemental dose at 2 hours (maximum 160 mg), or to an active-placebo arm receiving methylphenidate 30 mg (3 × 10 mg capsule) orally with an optional 10 mg supplemental dose at 2 hours (maximum 40 mg). Preparatory psychotherapy is delivered in the weeks before dosing, the combined dosing and psychotherapy session occurs at week 6, and integrative psychotherapy follows through weeks 7–16; adjunctive home psychotherapy modules are also used. Key outcomes include feasibility metrics and clinical measures such as PROMIS Pain Interference (primary clinical signal at 16 weeks), pain intensity, physical function, emotional function, overall improvement ratings and adverse events; each participant is followed for 16 weeks and the total study duration is 2 years.

Started
January 30, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07301632
Not yet recruitingPhase II

Safety and Efficacy of Lidocaine Versus Ketamine Infusion for Resistant Orofacial Pain

This Phase II, randomised, quadruple-masked, parallel trial (n=105) will evaluate the safety and efficacy of intravenous lidocaine, ketamine and a combined lidocaine–ketamine infusion in adults with treatment-resistant orofacial pain, with the primary outcome of pain reduction measured by the Visual Analog Scale (VAS). Interventions are lidocaine 5 mg/kg (max 500 mg) infused over 4 hours, ketamine 0.3 mg/kg infused over 4 hours, and a combined infusion of lidocaine 2.5 mg/kg plus ketamine 0.15 mg/kg infused over 4 hours. Participants will be randomised equally into three arms and receive their assigned slow intravenous infusion once weekly for three consecutive weeks with continuous cardiovascular and neurological/CNS monitoring during and after each infusion. Efficacy assessments occur at baseline, prior to the 2nd and 3rd infusions, and at 1, 3 and 6 months post-treatment; secondary measures include cortisol changes, depression assessment using PLAT‑Q and adverse event monitoring. Adults over 18 with orofacial pain refractory to standard therapies (including trigeminal neuralgia, TMJ dysfunction, malignant otitis externa, migraine or atypical facial pain) are eligible, and planned analyses include one-way ANOVA and repeated measures ANOVA for continuous outcomes.

Started
January 1, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07250867

Explore further

Search all Placebo papers Search all Chronic Pain trials Full Placebo profile Full Chronic Pain profile