Safety profile and pharmacokinetics of 4-Fluoroamphetamine (4-FA)

Safety profile and pharmacokinetics of 4-Fluoroamphetamine (4-FA) - Effects of a novel psychoactive sustance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45702

Enrollment

Registered

2017-09-15

Start date

2017-01-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Veiligheid not applicable

Interventions

0, 100 mg 4-FA

4-Fluoroamphetamine

Novel psychoactive substance

Pharmacokinetics

Safety profile

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Previous experience with psychostimulants (

Exclusion criteria

Exclusion criteria: • History of drug abuse or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Excessive drinking (> 20 alcoholic consumptions a week) • Pregnancy or lactation • Hypertension (diastolic> 90; systolic> 140) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Liver dysfunction • (Serious) side effects to previous psychostimulant use • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*) • Simultaneous participation in another clinical trial • For women: not using reliable contraceptive • Blood donor

Design outcomes

Primary

Measure	Time frame
vital signs; ECG, blood pressure, heart rate, saturation, respiratory, hematology, biochemistry and urinalysis	—

Secondary

Measure	Time frame
pharmacokinetics, cognitive performance and subjective experience	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)