Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat
Status:
Completed
Trial end date:
2020-04-30
Target enrollment:
Participant gender:
Summary
Gamma-hydroxybutyric acid (GHB) is a popular "party drug" because it is inexpensive and easy
to ingest. The calming and euphoric effects of GHB in low doses have given the drug the
nickname "liquid ecstasy". However, at doses >60 mg/kg coma, convulsions, and respiratory
depression can occur. If the drug combinates with alcohol these effects intensify, especially
respiratory depression and hypotension.
Lately a phenomenon called Chemsex has been spreading across big European cities. This is a
form of recreational drug use and it is believed that can be, in part, the cause of the
increasing in consumption of GHB. Chemsex is especially common among men who have sex with
other men (MSM) and in people living with HIV, with up to 50% of HIV-positive MSM reporting
to be engaged in chemsex in recent months. This population is specially concerning since the
combination of ART with the drug can cause pharmacological interactions leading to overdose.
Specifically, this study intends to evaluate the drug interaction with low doses of
cobicistat, an antiretroviral drug enhancer, since there are two case reports of
life-threatening overdoses in patients on treatment with high doses of another enhancer that
has a similar effect than cobicistat, but there are no studies about interactions with low
doses.
Phase:
Phase 1
Details
Lead Sponsor:
Fundacio Lluita Contra la SIDA Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia