Cannabis and dronabinol significantly increase caloric intake in HIV patients with loss of muscle mass.
Summary
n=30 HIV-positive cannabis users (n=15 with clinically significant loss of muscle mass <90% BCM/height, n=15 without), randomized comparison of dronabinol (10/20/30 mg) vs. inhaled cannabis (1,8/2,8/3,9% THC) vs. placebo; in subjects with wasting, significant increase in caloric intake under cannabis (all 3 doses) and dronabinol (10, 20 mg) vs. placebo (p<0.05); 30 mg dronabinol poorly tolerated in a subgroup; cognitive effects minor.
P
PopulationHIV-positive cannabis smokers with (n=15) and without (n=15) clinically significant loss of muscle mass (<90% body cell mass/height), total n=30
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InterventionOral dronabinol (0, 10, 20, 30 mg p.o.) and smoked cannabis (0,0; 1,8; 2,8; 3,9% THC) in 8 sessions of 7 hours each
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ControlPlacebo (0 mg dronabinol / 0,0% THC cannabis) in a double-dummy design
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OutcomeCaloric intake significantly increased under cannabis and dronabinol in the group with low BIA (loss of muscle mass), not in the group with normal BIA; 30 mg dronabinol poorly tolerated in a subgroup
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
<h4>Rationale</h4>No studies to date have directly compared the tolerability and efficacy of smoked Cannabis and oral dronabinol in HIV(+) Cannabis smokers.<h4>Objectives</h4>The aim of this study was to compare dronabinol (0, 10, 20, 30 mg p.o.) and Cannabis [0.0, 1.8, 2.8, 3.9% Delta(9)-tetrahydrocannabinol (THC)] in two samples of HIV(+) Cannabis 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.<h4>Methods</h4>Mood, physical symptoms, self-selected food intake, cardiovascular data, and cognitive task performance were measured before and repeatedly after dronabinol and Cannabis administration in eight 7-h sessions. Cannabis and dronabinol were administered in randomized order using a within-subject, staggered, double-dummy design.<h4>Results</h4>As compared to placebo, (1) Cannabis (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) Cannabis 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.<h4>Conclusions</h4>These data suggest that for experienced Cannabis smokers with clinically significant muscle mass loss, both dronabinol (at acute doses at least four to eight times the current recommendation) and Cannabis produce substantial and comparable increases in food intake without producing adverse effects.