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New treatment option for Obsessive-Compulsive Disorder
Official title Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
ClinicalTrials.gov ID: NCT07347405
What this study is testing
What is Psilocybin 10 mg?
Psilocybin 10 mg is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for obsessive-compulsive disorder.
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 tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study.
- Phase 1: an early, usually small safety study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years old, and older
- Have OCD (DSM-5) based on diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID).
- At least moderate severity: Yale-Brown Obsessive Compulsive Scale (YBOCS) score ≥16.
- Failed at least one adequate trial of guideline concordant treatment.
- Considered safe for independent living
You likely can't join if
- Concurrent active substance use disorder, or a personal history of psychosis.
- History of psychosis among first degree relatives as determined by the Family Interview for Genetic Studies (FIGS)32
- Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion...
- Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea
- Clinically significant renal or hepatic impairment, per clinical judgment of a study physician
- EKG QTc ≥ 450 msec
See the full eligibility criteria
- Aged 18 years old, and older
- Have OCD (DSM-5) based on diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID).
- At least moderate severity: Yale-Brown Obsessive Compulsive Scale (YBOCS) score ≥16.
- Failed at least one adequate trial of guideline concordant treatment.
- Considered safe for independent living
- people must discontinue use of any of the following prescription or over the counter (OTC) products or nutritional supplements at least two weeks prior to initiating blinded treatment:
- Monoamine oxidase (MAOI), UGT1A10, and UGT1A9 inhibitors
- Other active OCD treatments (cognitive behavioral therapy [CBT] or other psychotherapy; electrical or magnetic device treatments; pharmacological treatments such as antidepressant medications (e.g., SSRIs, SNRIs, MAOIs...
- 5HT2 agonists (e.g., efavirenz, lorcaserin), which may alter the response to psilocybin
- Serotonin-acting dietary supplements (e.g., 5-hydroxy-tryptophan, St. John's wort) due to potential for interaction with psilocybin and increased safety risks
- Concurrent active substance use disorder, or a personal history of psychosis.
- History of psychosis among first degree relatives as determined by the Family Interview for Genetic Studies (FIGS)32
- Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion. Examples include: 1) Cardiovascular conditions: lifetime history of...
- Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea
- Clinically significant renal or hepatic impairment, per clinical judgment of a study physician
- EKG QTc ≥ 450 msec
- Psychiatric comorbidity that may represent an acute risk to their own or other's safety, including history of bipolar disorder (I or II) in the participant or first degree relative, as well as any family history of...
- people cannot require any sedative, narcotic, or neuroleptic medications on a regular basis. Any of these medications they have taken should have been stopped long enough in the past to allow for their elimination and...
- Participants who are pregnant, breastfeeding, planning a pregnancy, or planning to donate sperm within three months post-last study drug administration.
- Participants of childbearing potential or participants with partners of childbearing potential who engage in intercourse which could result in pregnancy are unwilling/unable to practice medically acceptable highly...
- Suicide attempt within the 12 months prior to enrollment
- Any condition for which MRI is contraindicated, at the discretion of a study investigator or the MRI technician, including: Pacemakers and defibrillators; artificial heart valves which are not MRI safe; any metal in...
- Use within the week prior to screening of drugs of abuse as listed in the current US DOJ DEA Drugs of Abuse Resource Guide, including:
- Cannabinoids (marijuana, synthetic cannabinoids)
- Simulants (amphetamine, cocaine, methamphetamine, methylphenidate, modafinil)
- Opioids (natural and synthetic),
- Sedatives (benzodiazepines, barbiturates, GHB, zolpidem, zaleplon, zopiclone)
- Hallucinogens (DMT, ibogaine, LSD, MDMA, psilocybin, psilocin, PSP)
- Weight below 45kg
- Allergy or significant intolerance to chocolate or cocoa
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, 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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.