title: Acute psychotropic effects of oral cannabis extract with a defined content of Delta9-tetrahydrocannabinol (THC) in healthy volunteers.
abstract: BACKGROUND
  The medical use of cannabinoids is limited mainly by their undesirable effects. With respect to acute psychotropic effects, the aim of this study is the comparison of an oral cannabis extract and low-dose diazepam in a cross-over experiment in drug-naïve healthy women.
  
  
  METHODS
  Sixteen healthy females participated in this randomized, double-blind, active comparator-controlled, single-dose, balanced 2-way cross-over study. Cannabis extract with standardised Delta (9)-tetrahydrocannabinol (THC) content (20 mg) or active placebo (5 mg diazepam) was administered orally. Subjects were assessed by self- and observer-rated visual analogue scales (VAS), the BRIEF PSYCHIATRIC RATING SCALE (BPRS) and three psychomotor tests up to 6 h after administration.
  
  
  RESULTS
  VAS showed significantly elevated fatigue, drowsiness, dizziness, and "feeling high" after cannabis as compared to baseline and diazepam. BPRS scores were significantly higher after cannabis intake. Only in one psychomotor test a decrease of psychomotor activity after cannabis was evident. One subject in the cannabis condition experienced severe transient psychotic symptoms.
  
  
  CONCLUSIONS
  Orally administered cannabis produced significant central depressant side-effects compared to diazepam, mostly subjective effects (VAS) but marginal effects in psychomotor performance in 15 healthy females. Regarding the medical use of cannabis, a rigorous benefit-risk analysis and an exact psychiatric assessment before and during treatment are necessary.
authors.affiliation: Division of Biological Psychiatry, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. rainer.kaufmann@meduniwien.ac.at
authors.forename: R M
authors.initials: RM
authors.lastname: Kaufmann
authors.forename: B
authors.initials: B
authors.lastname: Kraft
authors.forename: R
authors.initials: R
authors.lastname: Frey
authors.forename: D
authors.initials: D
authors.lastname: Winkler
authors.forename: S
authors.initials: S
authors.lastname: Weiszenbichler
authors.forename: C
authors.initials: C
authors.lastname: Bäcker
authors.forename: S
authors.initials: S
authors.lastname: Kasper
authors.forename: H G
authors.initials: HG
authors.lastname: Kress
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D002188:Cannabis / Q000737:chemistry*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D013759:Dronabinol / Q000009:adverse effects*; D005260:Female; D006801:Humans; D010147:Pain Measurement; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics / Q000379:methods; D011597:Psychomotor Performance / Q000187:drug effects; D011618:Psychotic Disorders / Q000209:etiology*; D012649:Self Concept; D013997:Time Factors; D055815:Young Adult
chemical_list: D013759:Dronabinol