Subtherapeutic Dose of Piracetam as a Therapy Adherence Marker
Summary
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.
Timeline
- Start
- 2023-07-03
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Piracetam | Small molecule | 1.25 mg | — |
| Subject | Piracetam | Small molecule | 2.5 mg | — |
| Subject | Piracetam | Small molecule | 5 mg | — |
| Subject | Piracetam | Small molecule | 7.5 mg | — |
Indications
No indication recorded.