Subtherapeutic Dose of Piracetam as a Therapy Adherence Marker

NCT05918341 | Unknown Phase 4 FDA Drug

• 1 other identifier: N23PIR
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Drug Adherence Marker

Keywords

Drug adherence, adherence tracer, subtherapeutic dosing, quantitative urinalysis

Outcome Measures

Primary Outcomes (1)

• Primary Objective (detectability of piracetam in urine)

  To assess the feasibility of using a subtherapeutic dose of piracetam as a marker of adherence to therapy by determining whether this subtherapeutic dose produces a detectable concentration in the urine.

  24 hours after weekly ingestion of weekly dosage

Secondary Outcomes (1)

• Secondary Objective (piracetam concentration after nonadherence)

  72 hours after weekly ingestion of weekly dosage

Study Arms (1)

Piracetam arm (single arm)

EXPERIMENTAL

The single to take once weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg piracetam consecutively. Urine was collected 24 and 72 hours after the weekly doses were taken. It was chosen to administer all these doses in each healthy volunteer to account for inter-individual differences in urine concentrations, as these concentrations depend on individual characteristics such as volume intake and renal function.

Drug: Piracetam

Interventions

Piracetam DRUG

Subtherapeutic dose of piracetam (once-weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg)

Piracetam arm (single arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Able and willing to give written informed consent;
• Able and willing to undergo urine sampling for analysis;
• Able and willing to digest multiple tablets at day one of each study week (6 tablets of 1.25 mg in week 1; 4 tablets of 1.25 mg in week 2; 2 tablets of 1.25 mg in week 3 and 1 tablet of 1.25 mg in week 4.

You may not qualify if:

• Current prescribed treatment with piracetam;
• Pregnant or breastfeeding;
• Criteria regarding the following contra-indications for piracetam:
• Cerebral haemorrhage;
• Huntington's chorea;
• Hypersensitivity to pyrrolide derivatives.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

MeSH Terms

Conditions

Medication Adherence

Interventions

Piracetam

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alwin Huitema, Prof. Dr.

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke Leeuwerik, MSc

CONTACT

0031624321167; a.leeuwerik@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single center, open-label, uncontrolled study in 10 healthy volunteers who will receive various subtherapeutic doses of piracetam.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 3, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share