Pharmacokinetics of new dexamphetamine sustained release tablets and the clinical validation of measuring dexamphetamine in dried blood spots

Pharmacokinetics of new dexamphetamine sustained release tablets and the clinical validation of measuring dexamphetamine in dried blood spots - Dexamphetamine SR pharmacokinetics and validation of dried blood spots

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44699

Enrollment

Registered

2016-06-17

Start date

2016-10-31

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Middelenafhankelijkheid Addiction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Participate in a heroin assisted treatment program; 2. Have completed at least 80% of the study visits of the CATCH-study; 3. Be at least 25 years old; 4. Be able and willing to participate in the study treatment and assessments; 5. Have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any intake of dexamphetamine 7 days or less before the start of the proposed study; 2. Severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality). 3. (desired) Pregnancy or continued lactation; 4. Insufficient command of the Dutch language; 5. Current participation in another trial;

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic properties of the new dexamphetamine sustained release formulation and validation parameters for the measuring of dexamphetamine in dried blood spots.	—

Countries

Netherlands

Outcome results