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Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

NCT04322214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

  • Pharmacokinetic Interactions
  • HIV

Interventions

DRUG

Cobicistat 150 MG

once daily cobicistat (150 mg QD) for 5 days

DRUG

Placebo

once daily lactose capsules (as aspect cobicistat capsules)

DRUG

GHB

single oral dose of GHB (25 mg/kg) on days 5 and 17

Sponsors & Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    lead OTHER

Principal Investigators

  • José Moltó · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2020-03-30
Completion
2020-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322214 on ClinicalTrials.gov