The main objective of this study is to determine the release profile of the dexamphetamine sustained release tablets in vivo in humans. Depending on the results, the tablets might be candidates for use in the therapy of attention deficit…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Middelenafhankelijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic properties of the new dexamphetamine sustained release
formulation and validation parameters for the measuring of dexamphetamine in
dried blood spots.
Secondary outcome
Not applicable
Background summary
In November 2007, the research group of Prof. Wim van den Brink received a
research grant from ZonMW to conduct a pharmacotherapeutic study, in which they
planned to investigate, in three separate randomized controlled feasibility
trials, the effectiveness of topiramate, modafinil, and sustained release (SR)
dexamphetamine in the treatment of crack-cocaine dependent patients (MEC 09/197
# 11.17.0029).
Meanwhile, the topiramate and the modafinil trials have been finalized
and study reports have been produced and papers on these trials have been
published in a peer reviewed journals. In 2014, the dexamphetamine SR part of
this study started. However, in the Netherlands, there is no registered
formulation with sustained release available. Specially for this study, the
Hospital Pharmacy of the Slotervaart Hospital (now Antoni van Leeuwenhoek
Hospital) developed such a formulation. Extensive studies were carried out to
establish the in vitro dissolution characteristics of the tablets. Here, a
descriptive pharmacokinetic study of the dexamphetamine SR tablets is
presented.
In order to have a less burdening method to evaluate treatment
compliance of and to perform future pharmacokinetic studies with
dexamphetamine, the laboratory of the Antoni van Leeuwenhoek Hospital Pharmacy
developed a dried blood spot (DBS) analysis of dexamphetamine. The clinical
validation of this needs to be carried out with paired plasma samples and blood
spot. This is also described in this protocol.
Study objective
The main objective of this study is to determine the release profile of the
dexamphetamine sustained release tablets in vivo in humans. Depending on the
results, the tablets might be candidates for use in the therapy of attention
deficit hyperactivity disorder (ADHD), where now only an immediate release
tablet is available.
A second study objective is to assess whether the dried blood spot (DBS)
technique can be used to measure dexamphetamine concentrations instead of by
venipuncture in order to reduce subject burden.
Study design
The study will be conducted in a single treatment center. The design will be
that of a descriptive pharmacokinetic exploration study. Alongside, a clinical
validation will be carried out of the dried blood spot method for
dexamphetamine.
Study burden and risks
The burden for the first study day will be minimalized by giving the
participants a venflon needle. During the other study days, 1 to 2 blood
samples will be taken using venipuncture. A part of the CATCH-study group will
have received dexamphetamine in that study. Severe side-effects are not
expected in these patients. All participants will be monitored constantly by
the investigators and medical personel of the study site for possible side
effects. The burden for this study is deemed small.
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002403-29-NL |
| CCMO | NL53853.018.16 |