Chronic Low-back Pain study: Psilocybin vs Methylphenidate
Official title Psilocybin in Chronic Low Back Pain and Depression
ClinicalTrials.gov ID: NCT06355414
What this study is testing
What is Psilocybin?
This is an investigational medicine being studied to see if it might help with chronic low-back pain and depression. It is designed to interact with serotonin receptors in the brain to change how pain and mood are processed.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn how psilocybin affects pain and depression in people who have both conditions.
- Who it's for
- Adults who have long‑term low back pain and also feel depressed.
- What's involved
- Participants will receive either 25 mg of psilocybin or 40 mg of methylphenidate and will fill out questionnaires about pain, mood, and their experience during and after the session.
- Time commitment
- The study lasts a few weeks, with a single drug session and several follow‑up assessments afterward.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- 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...
- Report at least moderate depression symptoms Grid-Hamilton Depression Rating Scale (GRID-HAMD) ≥ 17
- Fluent in English
You likely can't join if
- Lifetime history of serious psychiatric (other than depression) or neurological disorders, including bipolar disorder, psychosis, or seizure disorder
- History (past 2 years) of severe substance use disorder or current (past six months) substance use disorder of moderate severity
- Clinically significant suicidal ideation (e.g. with strong intent or means) within past 6 months or history (past 5 years) of suicide attempt
- Medical condition incompatible with psilocybin administration (e.g., cardiovascular)
- On unstable/changing dose of opioid, benzodiazepine or other psychoactive or pain medication within 4 weeks prior to enrollment and/or unable to...
- Current use/positive toxicology for illicit drugs or positive breath alcohol test at screening and prior to each drug administration session.
See the full eligibility criteria
Who can join
- 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
- 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 the drug administration session
- Women who are of childbearing potential and sexually active who are not practicing an effective means of birth control must agree to practice an effective means of birth control throughout the duration of the study
- Be judged by study team clinicians to be at low risk for suicidality
- Concurrent psychotherapy or pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs), serotonin and norephinephrine reuptake inhibitors (SNRIs), and/or bupropion (\< 300 mg bupropion) is allowed if the type...
- Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study
- Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and...
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days.
- Agree not to take any as needed (PRN) medications on the mornings of drug sessions
- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration
- Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators.
- Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)
What rules you out
- Lifetime history of serious psychiatric (other than depression) or neurological disorders, including bipolar disorder, psychosis, or seizure disorder
- History (past 2 years) of severe substance use disorder or current (past six months) substance use disorder of moderate severity
- Clinically significant suicidal ideation (e.g. with strong intent or means) within past 6 months or history (past 5 years) of suicide attempt
- Medical condition incompatible with psilocybin administration (e.g., cardiovascular)
- On unstable/changing dose of opioid, benzodiazepine or other psychoactive or pain medication within 4 weeks prior to enrollment and/or unable to abstain from medication on drug administration day
- Current use/positive toxicology for illicit drugs or positive breath alcohol test at screening and prior to each drug administration session.
- Clinically significant transaminitis- aspertate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times normal value).
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing;
- Women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (QTc) interval (i.e...
- History of seizures and/or epilepsy with history of seizures.
- Type 1 diabetes.
- BMI \< 18
- Concomitant use of Monoamine oxidase inhibitors (MAOIs), or use within 14 days of MAOI discontinuation
- Family history or diagnosis of Tourette's syndrome
- Known Fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose insufficiency
- Glaucoma
- Known hypersensitivity to methylphenidate
- Marked agitation, anxiety, and tension
- Motor tics
- Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs.
- Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day
- Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.