Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobic… (NCT04322214) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat
Spain12 participantsStarted 2020-01-30
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females\* aging 18-45 years.
✓. Body weight ranging between 50 and 100 Kg.
✓. Previous experience with the consumption of sedatives (alcohol, cannabis, benzodiazepines, GHB or other hypnotics).
✓. Absence of abnormalities in the screening ECG and blood/urine tests.
✓. Agree with the study procedures and signature of the informed consent.
Exclusion criteria
✕. Prior history of medical or psychiatric adverse reaction following GHB consumption.
✕. Current substance use disorder (DSM-V, dependence, addiction) of any drug or substance of abuse.
✕. Prior history of substance use disorder (DSM-V, drug use disorder or addiction) of any drug or substance of abuse (except nicotine).
✕. Smokers\>10 cigarettes/day.
✕
What they're measuring
1
concentration in plasma of GHB
Timeframe: days 5 and 17
2
Proportion of participants reporting adverse events.
Timeframe: Since baseline to day 28
Trial details
NCT IDNCT04322214
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
. History of any physical condition or major surgery within the previous three months.
✕. History of individual psychiatric conditions or schizophrenia in first-degree relatives.
✕. History of gastrointestinal, hepatic, renal diseases or other conditions which, in opinion of the investigator, may affect drug absorption, distribution, metabolism or elimination.
✕. Alcohol intake higher than 4 units/day (40 g) in men or 2 units/day (20 g) in women.