Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT06102434
Eligibility Criteria:
Inclusion Criteria:
* Have a Body Mass Index from 18.5 - 34kg/m\^2
* Score of at least 3 on the Severity of Dependence Scale
* Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
* At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
* 0 use of a classical psychedelic in the last year
Exclusion Criteria:
* History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
* Abnormal electrocardiogram based on testing at study entrance
* A resting heart rate greater than 90 bpm
* Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
* Current use of antidepressants or other serotonergic-affecting substances
* History of cardiac conditions
* History of hepatic or renal impairments
* History of stroke or Transient Ischemic Attack
* Epilepsy or history of seizures
* Immediate family or personal history of psychosis, bipolar disorder, or schizophrenia
* Anxiety or mood disorders determined by the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V)
* Must not meet DSM-V criteria for any substance use disorders other than cocaine, caffeine, or nicotine
* Must not meet DSM-V criteria for borderline personality or dissociative disorders
* Current suicidal ideation or lifetime history of suicide attempts
* Arrest for a violent offense
* Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
* Women will not be eligible if trying to get pregnant, pregnant, or lactating
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT06102434
Study Brief:
Protocol Section:
NCT06102434