title: The subjective psychoactive effects of oral dronabinol studied in a randomized, controlled crossover clinical trial for pain.
abstract: BACKGROUND
  Many cannabinoid medications are approved in North America or in phase III trials, such as dronabinol, nabilone, or nabiximols. Little is known about their subjective psychoactive effects when used for pain management. We hypothesized that when used for pain, dronabinol has psychoactive effects in a dose-response relationship, whose peak effects are comparable with smoking marijuana.
  
  
  METHODS
  This was a randomized controlled trial of single dose placebo, 10 or 20 mg dronabinol in 30 chronic noncancer pain patients taking opioids and not using marijuana. Participants completed the Addiction Research Center Inventory (ARCI) hourly for 8 hours during 3 monitored sessions. Comparison sample was the ARCI ratings in participants with no pain (N=20), monitored every 30 minutes after smoking a 1.99% THC (low) and a 3.51% (high strength) marijuana cigarette.
  
  
  RESULTS
  The 10 and 20 mg dronabinol doses had significantly elevated scores over time on 4/5 subscales versus placebo (P<0.05). Average daily morphine use, total pain relief (TOTPAR), age, sex, and baseline pain level were not significant covariates. ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes (P=0.80, 10 mg=low strength, 20 mg=high strength).
  
  
  CONCLUSIONS
  In pain patients, oral dronabinol has similar psychoactive effects to smoking marijuana. This risk must be considered in any decision to prescribe cannabinoid medications for pain.
authors.affiliation: Departments of *Anesthesiology, Perioperative, and Pain Medicine ‡Psychiatry, Brigham and Women's Hospital §Behavioral Psychopharmacology Research Laboratory, McLean Hospital †Harvard Medical School, Boston, MA.
authors.forename: Mohammed A
authors.initials: MA
authors.lastname: Issa
authors.forename: Sanjeet
authors.initials: S
authors.lastname: Narang
authors.forename: Robert N
authors.initials: RN
authors.lastname: Jamison
authors.forename: Edward
authors.initials: E
authors.lastname: Michna
authors.forename: Robert R
authors.initials: RR
authors.lastname: Edwards
authors.forename: David M
authors.initials: DM
authors.lastname: Penetar
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use; D059350:Chronic Pain / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D013759:Dronabinol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008385:Marijuana Smoking / Q000503:physiopathology; D064086:Medical Marijuana / Q000627:therapeutic use; D008875:Middle Aged; D009020:Morphine / Q000627:therapeutic use; D010147:Pain Measurement; D008517:Phytotherapy; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D064086:Medical Marijuana; D011619:Psychotropic Drugs; D009020:Morphine; D013759:Dronabinol