Dronabinol erhöhte die Kalorienaufnahme und verbesserte den Schlaf nur initial (Tage 1–8), mit Toleranzentwicklung bei wiederholter Gabe, jedoch anhaltender Stimmungsverbesserung.
Zusammenfassung
n=7 HIV-positive Cannabiskonsumenten; Dronabinol 10 mg QID vs. Placebo in 2×16-tägigen Inpatient-Phasen; Kalorienaufnahme in den ersten 8 Tagen signifikant erhöht, danach selektive Toleranzentwicklung; Stimmungsverbesserung über 16 Tage anhaltend; keine relevanten kognitiven oder psychotropen Nebenwirkungen; Tagesdosis >FDA-Empfehlung nötig bei HIV+-Konsumenten.
P
PopulationHIV-positive Cannabisraucher unter antiretroviraler Therapie, n=7
I
InterventionDronabinol (THC) 10 mg 4×täglich oral über 16 Tage (inpatient)
C
KontrollePlacebo (doppelblind, Crossover)
O
OutcomeKalorienaufnahme nur in den ersten 8 Tagen signifikant erhöht; Schlafqualität ebenfalls nur in Phase 1 verbessert; Stimmungsverbesserung über 16 Tage anhaltend; gute Verträglichkeit
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
<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.