Margaret Haney1, Judith Rabkin, Erik Gunderson, Richard W Foltin. 1. New York State Psychiatric Institute, College of Physicians and Surgeons of Columbia University, 1051 Riverside Dr., Unit 120, New York, NY 10032, USA. mh235@columbia.edu
Abstract
RATIONALE: No studies to date have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol in HIV(+) marijuana smokers. OBJECTIVES: The aim of this study was to compare dronabinol (0, 10, 20, 30 mg p.o.) and marijuana [0.0, 1.8, 2.8, 3.9% Delta(9)-tetrahydrocannabinol (THC)] in two samples of HIV(+) marijuana smokers: those with (n=15) and those without (n=15) a clinically significant loss of muscle mass (<90% body cell mass/height), which is one component of AIDS wasting. METHODS:Mood, physical symptoms, self-selected food intake, cardiovascular data, and cognitive task performance were measured before and repeatedly after dronabinol and marijuana administration in eight 7-h sessions. Marijuana and dronabinol were administered in randomized order using a within-subject, staggered, double-dummy design. RESULTS: As compared to placebo, (1) marijuana (1.8, 2.8, 3.9% THC) and the lower dronabinol doses (10, 20 mg) were well tolerated (e.g., few physical symptoms, significant increases in ratings of "good drug effect") in both groups of participants; the highest dose of dronabinol (30 mg) was poorly tolerated in a subset of participants; (2) marijuana and dronabinol significantly increased caloric intake in the low bioelectrical impedance analysis (BIA) group but not in the normal BIA group; and (3) drug effects on cognitive performance were minor. CONCLUSIONS: These data suggest that for experienced marijuana smokers with clinically significant muscle mass loss, both dronabinol (at acute doses at least four to eight times the current recommendation) and marijuana produce substantial and comparable increases in food intake without producing adverse effects.
RCT Entities:
RATIONALE: No studies to date have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol in HIV(+) marijuana smokers. OBJECTIVES: The aim of this study was to compare dronabinol (0, 10, 20, 30 mg p.o.) and marijuana [0.0, 1.8, 2.8, 3.9% Delta(9)-tetrahydrocannabinol (THC)] in two samples of HIV(+) marijuana smokers: those with (n=15) and those without (n=15) a clinically significant loss of muscle mass (<90% body cell mass/height), which is one component of AIDS wasting. METHODS: Mood, physical symptoms, self-selected food intake, cardiovascular data, and cognitive task performance were measured before and repeatedly after dronabinol and marijuana administration in eight 7-h sessions. Marijuana and dronabinol were administered in randomized order using a within-subject, staggered, double-dummy design. RESULTS: As compared to placebo, (1) marijuana (1.8, 2.8, 3.9% THC) and the lower dronabinol doses (10, 20 mg) were well tolerated (e.g., few physical symptoms, significant increases in ratings of "good drug effect") in both groups of participants; the highest dose of dronabinol (30 mg) was poorly tolerated in a subset of participants; (2) marijuana and dronabinol significantly increased caloric intake in the low bioelectrical impedance analysis (BIA) group but not in the normal BIA group; and (3) drug effects on cognitive performance were minor. CONCLUSIONS: These data suggest that for experienced marijuana smokers with clinically significant muscle mass loss, both dronabinol (at acute doses at least four to eight times the current recommendation) and marijuana produce substantial and comparable increases in food intake without producing adverse effects.
Authors: Bradley W Kosel; Francesca T Aweeka; Neal L Benowitz; Starley B Shade; Joan F Hilton; Patricia S Lizak; Donald I Abrams Journal: AIDS Date: 2002-03-08 Impact factor: 4.177
Authors: Carl L Hart; Margaret Haney; Amie S Ward; Marian W Fischman; Richard W Foltin Journal: Drug Alcohol Depend Date: 2002-08-01 Impact factor: 4.492
Authors: J P Palenicek; N M Graham; Y D He; D A Hoover; J S Oishi; L Kingsley; A J Saah Journal: J Acquir Immune Defic Syndr Hum Retrovirol Date: 1995-11-01
Authors: Donald I Abrams; Joan F Hilton; Roslyn J Leiser; Starley B Shade; Tarek A Elbeik; Francesca T Aweeka; Neal L Benowitz; Barry M Bredt; Bradley Kosel; Judith A Aberg; Steven G Deeks; Thomas F Mitchell; Kathleen Mulligan; Peter Bacchetti; Joseph M McCune; Morris Schambelan Journal: Ann Intern Med Date: 2003-08-19 Impact factor: 25.391
Authors: J E Beal; R Olson; L Laubenstein; J O Morales; P Bellman; B Yangco; L Lefkowitz; T F Plasse; K V Shepard Journal: J Pain Symptom Manage Date: 1995-02 Impact factor: 3.612
Authors: Jonathan A Farrimond; Andrew J Hill; Benjamin J Whalley; Claire M Williams Journal: Psychopharmacology (Berl) Date: 2010-03-27 Impact factor: 4.530
Authors: Gregory E Harris; Lise Dupuis; Gerald J Mugford; Lynn Johnston; David Haase; Ginny Page; Heather Haldane; Nicholas Harris; William K Midodzi; Gordon Dow Journal: Can J Infect Dis Med Microbiol Date: 2014 Impact factor: 2.471