Detect GHB

Phase 1

• Conditions: Intoxication; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-501329-18-00
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study Completion: 2023-07-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy volunteers aged 18-65 years, Informed, written consent, Able to understand Danish

Exclusion Criteria

Current or previous substance abuse or alcohol abuse, A psychiatric disorder that requires medical treatment, incl. major depression, Pregnant and breastfeeding women (Fertile women (defined as amenorrhea for less than 12 months) must have a negative HCG pregnancy test prior to intake of the trial medication), Current or previous treatment with GHB, Treatment with valproate or topiramate, Treatment with benzodiazepines, opioids, or another CNS-depressant medicinal product, Hypersensitive to sodium oxybate or any of the excipients of Sodium Oxybate (i.e. malic acid and sodium hydroxide), Succinic semialdehyde dehydrogenase deficiency, History of impaired hepatic or renal function, A diagnosis of epilepsy, A diagnosis of porphyria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified