Drug test detection 24 hours after giving cocaine through the nose to contract the blod vessels in it

Drug test detection 24 hours after nasal administration of cocaine as a local vasoconstrictor prior to nasal intubation

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000709-26-DK

Enrollment

Registered

2022-01-18

Start date

2022-01-18

Completion date

Unknown

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual systemic cocaine after administration as local nasal vasoconstrictor MedDRA version: 22.0 Level: LLT Classification code 10013685 Term: Drug effect prolonged System Organ Class: 100000004867

Interventions

Product Name: Kokain øjendråber, opløsning, 40mg/ml (4%) Pharmaceutical Form: Nasal spray INN or Proposed INN: Cocaine CAS Number: 53-21-4 Other descriptive name: COCAINE HYDROCHLORIDE Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years • Scheduled for nasal intubation • Proficient in spoken and written Danish • Negative baseline cocaine saliva test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Intubation to be done on awake patient • Pregnancy in fertile women (Women under the age of 50 must produce a negative hCG urine stix to participate) • Known symptomatic coronary artery disease (As declared by patient or noted in the patient’s file) • Untreated hypertension ( As declared by patient or noted in the patient’s file + Not taking antihypertension drugs )

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine in saliva or its main metabolite benzoylecgonine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa. ;Secondary Objective: Not applicable;Primary end point(s): Qualitative binary result of saliva analysis testing for cocaine ;Timepoint(s) of evaluation of this end point: 1) On morning of operation 2) 60 minutes after cocaine administration 3) 24 hours after cocaine administration	—

Measure

Time frame

Main Objective: The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine in saliva or its main metabolite benzoylecgonine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa. ;Secondary Objective: Not applicable;Primary end point(s): Qualitative binary result of saliva analysis testing for cocaine ;Timepoint(s) of evaluation of this end point: 1) On morning of operation 2) 60 minutes after cocaine administration 3) 24 hours after cocaine administration

—

Secondary

Measure	Time frame
Secondary end point(s): Whole blood toxicology measuring cocaine;Timepoint(s) of evaluation of this end point: 1) On morning of operation 2) 60 minutes after cocaine administration 3) 24 hours after cocaine administration	—

Countries

Denmark

Contacts

Public ContactDepartment of Anesthesiology

Rigshospitalet, Centre of Head and Orthopaedics

anop-hoc.rigshospitalet@regionh.dk+4535453474

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026