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

Completed

• Conditions: Middelenafhankelijkheid; Addictive behaviour; Addiction

• Registration Number: NL-OMON44699
• Lead Sponsor: Di-AcetylM B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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;

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic properties of the new dexamphetamine sustained release<br /><br>formulation and validation parameters for the measuring of dexamphetamine in<br /><br>dried blood spots.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>