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NCT05918341

Subtherapeutic Dose of Piracetam as a Therapy Adherence Marker

Status unknown Phase 4 Last updated 26 June 2023
What this trial tests

Phase 4 trial testing Piracetam in Drug Adherence Marker in 10 participants. Status unknown.

Timeline
3 July 2023
Primary endpoint
30 September 2023
30 September 2023

Quick facts

Lead sponsorThe Netherlands Cancer Institute
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment10
Start date3 July 2023
Primary completion30 September 2023
Estimated completion30 September 2023

Drugs / interventions tested

Conditions studied

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, any sex, with Drug Adherence Marker. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to test a subtherapeutic dose of piracetam in healthy volunteers as a marker of adherence to therapy to assess the feasibility of its use in a multicentre, randomised, double-blind, placebo-controlled study of the efficacy of dexamphetamine in cocaine dependence (CUD) with comorbid opioid addiction (REDUCE study). Several markers for assessing adherence have been described in the literature. However, none of these markers qualified for use within the targeted patient population. Therefore, a suitable adherence marker was sought specifically for the study design of the REDUCE trial. Since within the REDUCE trial urine is submitted biweekly by participants for measuring cocaine use, the adherence marker will also be determined in this matrix. The most suitable marker seems to be piracetam. However, within this study with healthy volunteers, it will first have to be confirmed whether detectable concentrations of piracetam are actually excreted in the urine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Piracetam

Trials testing the same drug.

Other The Netherlands Cancer Institute trials

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Data sources for this page

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