Cocaine AddictionEarly Phase 1NCT02768441
Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots
A Early Phase 1 study testing Dexamphetamine in people with Cocaine Addiction, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- Dexamphetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2016to 1 Jun 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have completed at least 80% of the previous study (CATCH)
- Be able and willing to participate in the study and assessments
- Have provided written informed consent.
Who cannot join
- Any intake of dexamphetamine 7 days or less before the start of the proposed study;
- Contraindications for dexamphetamine
- (desired) pregnancy or continued lactation
- Insufficient command of the Dutch language
- Current participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots
The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.
- Conditions
- Cocaine Addiction
- Being tested
- Dexamphetamine
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamphetamineDrug
Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Participants receiving Dexamphetamine 60 mg SR Receives: Drug: Dexamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Curve (AUC) of dexamphetamine
Measured: Determined on the 5 day bloodsamples taken
Maximum plasma concentration (Cmax) of dexamphetamine
Measured: Determined on the 5 day bloodsamples taken
Half life (T 1/2) of dexamphetamine
Measured: Determined on the 5 day bloodsamples taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Nov 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim van den Brink, PhD, Principal investigator, Academic Psychiatric Center AMC-UvA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768441
- Sponsor's protocol ID
- DAM001DFM
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots
- ClinicalTrials.gov ID
- NCT02768441
- Acronym / sponsor ID
- DAM001DFM
- Conditions
- Cocaine Addiction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: DexamphetamineParticipants receiving Dexamphetamine 60 mg SR |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have completed at least 80% of the previous study (CATCH)
- Be able and willing to participate in the study and assessments
- Have provided written informed consent.
Key exclusion criteria (5 listed)
- Any intake of dexamphetamine 7 days or less before the start of the proposed study;
- Contraindications for dexamphetamine
- (desired) pregnancy or continued lactation
- Insufficient command of the Dutch language
- Current participation in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamphetamineParticipants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days | Drug | Study group |
Primary outcome
Area under the Curve (AUC) of dexamphetamine
Time frame: Determined on the 5 day bloodsamples taken
Maximum plasma concentration (Cmax) of dexamphetamine
Time frame: Determined on the 5 day bloodsamples taken
Half life (T 1/2) of dexamphetamine
Time frame: Determined on the 5 day bloodsamples taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim van den Brink, PhD principal investigator
Academic Psychiatric Center AMC-UvA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamphetamine in people with Cocaine Addiction, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Curve (AUC) of dexamphetamine (time frame: Determined on the 5 day bloodsamples taken). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.