Visszavonva2. fázis
Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
A legfontosabb adatok
- Ki végzi
- University of Maryland, Baltimore
- Hol
- Baltimore, Catonsville és Los Angeles (Egyesült Államok)Mind a 3 helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 2. fázis
- Kezdés
- 2050. jan.
- Várható befejezés
- 2050. márc.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Cannabidiol (CBD)
- Placebo
- A regiszteradat frissítve
- 2021. április 19.
- Miért állt le
- not funded
Ki vehet részt
- Életkor
- 18 év – 35 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 23 feltétel megnézéseKevesebb
Ki vehet részt
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, and other specified or unspecified schizophrenia spectrum and other psychotic disorder
- Experienced a first psychotic episode within the last 5 years
- Self-reported cannabis use at least twice/week for at least the last 4 weeks
- THCCOOH serum levels of ≥ 5 ng/mL
- Total score ≥45 on the 18-item version of the Brief Psychiatric Rating Scale
- Able to give written informed consent
- Normal or corrected to normal vision
- If medicated, no change in psychiatric medication within the preceding 4 weeks, with no foreseeable changes
Ki nem vehet részt
- Use of any barbiturates, diazepam, diltiazem, verapamil, protease inhibitors, any anticonvulsant medications (including valproate/valproic acid, lamotrigine, carbamazepine, and clobazam), glipizide, glyburide, warfarin, and cyclophosphamide/ ifosfamide, due to potential interaction with CBD at the metabolic level
- DSM-5 diagnosis of Substance Use Disorder other that cannabis or nicotine within the last year (recreational use is not exclusionary)
- Currently undergoing active treatment for Cannabis Use Disorder other than low-level (once/week or less) psychosocial intervention
- Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg)
- History of or current neurological illness, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome
- Diabetes
- Significant kidney or liver impairment
- Any chronic or severe infectious disease, including HIV and hepatitis
- Cancer
- Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval <120 ms or >200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min)
- Less than the lower limit of normal hemoglobin and hematocrit at screening
- Elevated transaminase levels >3 times the ULN, accompanied by elevations in bilirubin >2 times the ULN
- Intellectual disability
- Pregnant or lactating
- Suicidal ideation currently or within last 6 months (score of >/= 3 on the Columbia Suicide Severity Rating Scale)
Helyszínek itt: Egyesült Államok
- Sheppard Pratt Health SystemBaltimore, Egyesült ÁllamokNo longer taking part
- Maryland Psychiatric Research CenterCatonsville, Egyesült ÁllamokNo longer taking part
- Semel Institute for Neuroscience and Human BehaviorLos Angeles, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.
A vizsgálat 2 csoportja
- Cannabidiol (CBD)A vizsgált kezelés
Participants receive CBD daily for 12 weeks.
- PlaceboPlacebo, összehasonlításként
Participants receive vehicle not containing any drug daily for 12 weeks.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2021. április 19.