Dronabinol increased caloric intake and improved sleep only initially (days 1–8), with tolerance development upon repeated administration, but sustained mood improvement.
Summary
n=7 HIV-positive cannabis users; dronabinol 10 mg QID vs. placebo in 2×16-day inpatient phases; caloric intake significantly increased in the first 8 days, followed by selective tolerance development; mood improvement sustained over 16 days; no relevant cognitive or psychotropic side effects; daily dose >FDA recommendation necessary in HIV+ users.
P
PopulationHIV-positive cannabis smokers under antiretroviral therapy, n=7
I
InterventionDronabinol (THC) 10 mg 4×daily orally over 16 days (inpatient)
C
ControlPlacebo (double-blind, crossover)
O
OutcomeCaloric intake significantly increased only in the first 8 days; sleep quality likewise improved only in phase 1; mood improvement sustained over 16 days; good tolerability
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
<h4>Rationale</h4>Dronabinol (Δ(9)tetrahydrocannabinol) is approved for HIV-related anorexia, yet, little is known about its effects in HIV-positive Cannabis smokers. HIV-negative Cannabis smokers require higher than recommended dronabinol doses to experience expected effects.<h4>Objectives</h4>Employing a within-subjects, double-blind, placebo-controlled design, we assessed the effects of repeated high-dose dronabinol in HIV-positive Cannabis smokers taking antiretroviral medication.<h4>Methods</h4>Participants (N = 7), who smoked Cannabis 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.<h4>Results</h4>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.<h4>Conclusions</h4>In HIV-positive Cannabis 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 Cannabis 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.