title: Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers.
abstract: Cannabidiol (CBD) is a naturally occurring constituent of the marijuana plant. In the past few years, there has been great interest in the therapeutic effects of isolated CBD and it is currently being explored for numerous disease conditions (e.g., pain, epilepsy, cancer, various drug dependencies). However, CBD remains a Schedule I drug on the U.S. Controlled Substances Act (CSA). Despite its status, there are no well-controlled data available regarding its abuse liability.
  
  
  
  Healthy, frequent marijuana users (n=31) were enrolled in this within subject, randomized, placebo-controlled, double-blind, multisite study that administered oral cannabidiol (0, 200, 400, 800mg) alone and in combination with smoked marijuana (0.01%, 5.3-5.8% THC). Participants received one dose combination across 8 once-weekly outpatient sessions (7.5h). The primary findings on the drug interaction effects were previously reported (Haney et al., 2016). The present study is a secondary analysis of the data to examine the abuse liability profile of oral cannabidiol (200, 400, 800mg) in comparison to oral placebo and active smoked marijuana (5.3-5.8% THC).
  
  
  
  Active marijuana reliably produced abuse-related subjective effects (e.g., high) (p<0.05). However, CBD was placebo-like on all measures collected (p>0.05).
  
  
  
  Overall, CBD did not display any signals of abuse liability at the doses tested and these data may help inform U.S. regulatory decisions regarding CBD schedule on the CSA.
authors.affiliation: University of Kentucky, Department of Behavioral Science, Center on Drug and Alcohol Research, Lexington, KY, USA. Electronic address: babalonis@uky.edu.
authors.forename: Shanna
authors.initials: S
authors.lastname: Babalonis
authors.affiliation: Columbia University Medical Center, Division on Substance Abuse, New York State Psychiatric Institute and the Department of Psychiatry, New York, NY, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Haney
authors.affiliation: Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Malcolm
authors.affiliation: University of Kentucky, Department of Behavioral Science, Center on Drug and Alcohol Research, Lexington, KY, USA.
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Lofwall
authors.affiliation: McLean Hospital, Division of Alcohol and Drug Abuse, Belmont, MA, USA.
authors.forename: Victoria R
authors.initials: VR
authors.lastname: Votaw
authors.affiliation: National Institute on Drug Abuse, Bethesda, MD, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Sparenborg
authors.affiliation: University of Kentucky, Department of Behavioral Science, Center on Drug and Alcohol Research, Lexington, KY, USA.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Walsh
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002185:Cannabidiol / Q000494:pharmacology*; D004311:Double-Blind Method; D004347:Drug Interactions; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D002189:Marijuana Abuse / Q000523:psychology*; D008385:Marijuana Smoking / Q000523:psychology*; D008875:Middle Aged; D011597:Psychomotor Performance / Q000187:drug effects; D055815:Young Adult
chemical_list: D002185:Cannabidiol
keywords: Abuse liability; CBD; Cannabidiol; Human; Smoked marijuana