Dronabinol and Cannabis in HIV-Positive Cannabis Smokers

Haney et al. ·JAIDS Journal of Acquired Immune Deficiency Syndromes Impact 2.2

Clear benefit GRADE Moderate 182 citations

Samplen = 10 Pat.

Duration2 × 16-day phases

ControlPlacebo

EndpointDaily caloric intake

Blindingdoppelblind

DesignRCT (cross-over)

Cannabinoidthc

Max. dose40.0 mg

Key finding

Both dronabinol and cannabis dose-dependently increased daily caloric intake and body weight in HIV-positive individuals, were well tolerated, and showed comparable effects, with improvement in sleep ratings only from higher-dose cannabis.

Summary

n=10 HIV-positive cannabis users, placebo-controlled cross-over study of dronabinol (5/10 mg) and cannabis (2,0%/3,9% THC) 4×daily over 4 days each. Both cannabinoids dose-dependently increased caloric intake and body weight compared to placebo; both well tolerated with comparable efficacy, only cannabis (3,9% THC) additionally improved sleep quality.

PopulationHIV-positive cannabis users, n=10

InterventionDronabinol (5 mg and 10 mg oral, 4×/day) and cannabis (2,0% and 3,9% THC, smoked, 4×/day), each over 4 days in an inpatient cross-over design

ControlPlacebo (double-blind)

OutcomeBoth cannabinoids dose-dependently increased daily caloric intake and body weight compared to placebo; cannabis (3,9% THC) additionally improved sleep ratings; cognitive performance unimpaired

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size Clear benefit

Citations / year ★★★★★

Authors

Haney M, Gunderson E W, Rabkin J et al.

DOI 10.1097/qai.0b013e31811ed205↗

Design: RCT (cross-over)

Abstract

Objectives: Individuals with HIV constitute the largest group using cannabinoids for medicinal reasons; yet, no studies have directly compared the tolerability and efficacy of smoked Cannabis and oral dronabinol maintenance in HIV-positive Cannabis smokers. This placebo-controlled within-subjects study evaluated Cannabis and dronabinol across a range of behaviors: eating topography, mood, cognitive performance, physiologic measures, and sleep. Methods: HIV-positive Cannabis smokers (n = 10) completed 2 16-day inpatient phases. Each dronabinol (5 and 10 mg) and Cannabis (2.0% and 3.9% Delta9-tetrahydrocannabinol [THC]) dose was administered 4 times daily for 4 days, but only 1 drug was active per day, thereby maintaining double-blind dosing. Four days of placebo washout separated each active cannabinoid condition. Results: As compared with placebo, Cannabis and dronabinol dose dependently increased daily caloric intake and body weight in HIV-positive Cannabis smokers. All cannabinoid conditions produced significant intoxication, except for low-dose dronabinol (5 mg); the intoxication was rated positively (eg, "good drug effect") with little evidence of discomfort and no impairment of cognitive performance. Effects of Cannabis and dronabinol were comparable, except that only Cannabis (3.9% THC) improved ratings of sleep. Conclusions: These data suggest that for HIV-positive Cannabis smokers, both dronabinol (at doses 8 times current recommendations) and Cannabis were well tolerated and produced substantial and comparable increases in food intake.

The impediment to action advances action. — Marcus Aurelius