title: Efficacy and tolerability of high-dose dronabinol maintenance in HIV-positive marijuana smokers: a controlled laboratory study.
abstract: BACKGROUND
  Dronabinol (Δ(9)tetrahydrocannabinol) is approved for HIV-related anorexia, yet, little is known about its effects in HIV-positive marijuana smokers. HIV-negative marijuana smokers require higher than recommended dronabinol doses to experience expected effects.
  
  
  OBJECTIVE
  Employing a within-subjects, double-blind, placebo-controlled design, we assessed the effects of repeated high-dose dronabinol in HIV-positive marijuana smokers taking antiretroviral medication.
  
  
  METHODS
  Participants (N = 7), who smoked marijuana 4.2 ± 2.3 days/week, resided in a residential laboratory for two 16-day stays, receiving dronabinol (10 mg QID) in one stay and placebo in the other. Efficacy was assessed with objectively verified food intake and body weight. Tolerability was measured with sleep, subjective, and cognitive assessments. For analyses, each inpatient stay was divided into two phases, days 1-8 and 9-16; we compared dronabinol's effects with placebo in each 8-day phase to investigate tolerance.
  
  
  RESULTS
  Despite sustained increases in self-reported food cravings, dronabinol only increased caloric intake in the initial 8 days of dosing. Similarly, sleep quality was improved only in the first 8 days of dosing. Dronabinol's mood-enhancing effects were sustained across the 16-day inpatient stay. Dronabinol was well tolerated, causing few negative subjective or cognitive effects.
  
  
  CONCLUSIONS
  In HIV-positive marijuana smokers, high dronabinol doses safely and effectively increased caloric intake. However, repeated high-dose dronabinol appeared to result in selective tolerance to these effects. These findings indicate that HIV-positive individuals who smoke marijuana may require higher dronabinol doses than are recommended by the FDA. Future research to establish optimal dosing regimens, and reduce the development of tolerance, is required.
authors.affiliation: Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
authors.forename: Gillinder
authors.initials: G
authors.lastname: Bedi
authors.forename: Richard W
authors.initials: RW
authors.lastname: Foltin
authors.forename: Erik W
authors.initials: EW
authors.lastname: Gunderson
authors.forename: Judith
authors.initials: J
authors.lastname: Rabkin
authors.forename: Carl L
authors.initials: CL
authors.lastname: Hart
authors.forename: Sandra D
authors.initials: SD
authors.lastname: Comer
authors.forename: Suzanne K
authors.initials: SK
authors.lastname: Vosburg
authors.forename: Margaret
authors.initials: M
authors.lastname: Haney
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D000855:Anorexia / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology / Q000821:virology; D019167:Appetite Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D001835:Body Weight / Q000187:drug effects; D003071:Cognition / Q000187:drug effects; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage* / Q000009:adverse effects; D004361:Drug Tolerance; D004435:Eating / Q000187:drug effects; D002149:Energy Intake / Q000187:drug effects; D005247:Feeding Behavior / Q000187:drug effects*; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D008385:Marijuana Smoking / Q000503:physiopathology / Q000523:psychology*; D009519:New York City; D015990:Placebo Effect; D012890:Sleep / Q000187:drug effects; D012919:Social Behavior; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019167:Appetite Stimulants; D013759:Dronabinol
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