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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.