Blood levels of dexamphetamine sustained release tablets and the review of the usefulness of measuring dexamphetamine in dried blood spots

Phase 1

• Conditions: o condition is investigated. The primary aim is to investigate the pharmacokinetics of the new formulation; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2015-002403-29-NL
• Lead Sponsor: Di-AcetylM B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-11
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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), which constitute a contraindication for participation;
3.(desired) Pregnancy or continued lactation;
4.Insufficient command of the Dutch language;
5.Current participation in another trial;

Study & Design

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