Cocaine Adverse ReactionNCT05334056
Drug Test Detection of Cocaine for Nasal Intubation
An observational study of Cocaine Adverse Reaction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine's main metabolite benzoylecgonine in saliva or cocaine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Adverse Reaction
- What is being tested?
- Cocaine Nasal
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2023to 27 May 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients schedualed to undergo surgery at Rigshospitalet with the use of nasal intubation.
Who may be able to join
- Age ≥ 18 years
- Scheduled for nasal intubation
- Proficient in spoken and written Danish
- Negative baseline cocaine saliva test
Who cannot join
- Intubation to be done on awake patient
- Pregnancy
- Women of childbearing potential 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Test Detection 24 Hours After Nasal Administration of Cocaine as a Local Vasoconstrictor Prior to Nasal Intubation
The objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine's main metabolite benzoylecgonine in saliva or cocaine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa.
The investigators hypothesize that the level of cocaine's main metabolite bezoylecgonine in saliva after cocaine administered for anesthetic purposes will be below detection limits after 24 hours.
Read the detailed description
When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. Prior to nasal intubation the mucosa must be sufficiently lubricated and decongested in order to minimize epistaxis. When intubation is performed on awake patients anesthesia of the nose is also necessary. Cocaine has for many years been used for both decongestive and anesthetic purposes due to its unique pharmacodynamic profile. When applied to the nasal mucosa its vasoconstrictive quality aids in facilitating the inspection of the nasal cavity whilst the anesthetic effect allows for manipulation within the cavity. The vasoconstriction arises through cocaine's ability to inhibit the reuptake and metabolism of catecholamines, which then in greater concentration has adrenergic effects. By binding to and blocking axonal membrane sodium channels, cocaine interferes with the propagation of action potentials and thereby also exerts an analgesic effect.
Along with other countries Denmark has a legal zero tolerance policy for a long list of drugs in drivers including cocaine. During routine screenings or if the police suspect a driver to be under the influence of illegal drugs, they will first complete a qualitative saliva analysis testing for cocaine's main metabolite benzoyelecgonine. If the test comes out positive or there are clinical signs of drug influence, a supplementary blood sample measuring cocaine will be drawn and analyzed for use in the legal system. Repercussions from a cocaine test value exceeding the legal limit consists of a large fine, driver's license revocation and mandatory participation in a drug and alcohol course, neither of which seems fair to inflict on the uninformed and consequently unaware patient.
Pharmacokinetics for nasal cocaine have been described but no studies defining proper instructional driving precautions appear to exist. One study recommended patients be informed and consent prior to cocaine administration and be warned they may fail a drug test up to 72 hours postoperatively but as of 2021 patients are in many countries - including Denmark - still not informed about this time limit.
When administered in doses thought to avoid systemic effects, cocaine is a safe local anesthetic agent. The recommended dosage varies considerably throughout the literature with safe doses ranging between 1.5-3.0 mg/kg. The amount of cocaine absorbed has in one study been found to be 5% but has not been subsequently verified. The dosage of cocaine used prior to nasal intubation in Denmark is typically 1-2 ml of 4% cocaine resulting in a total dose of 40-80 mg. The typical 'street dose' is 40-100 mg. The Danish cut-off values for detection of cocaine's main metabolite benzoylecgonine is 200 ng/ml in saliva and 0.01 mg/kg in whole blood.
The investigators wish to evaluate whether cocaine levels exceed detection limits 24 hours after administration prior to nasal intubation.
- Conditions
- Cocaine Adverse Reaction
- Being tested
- Cocaine Nasal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocaine NasalDrug
Also called Cocaine 4%
2 ml of 4% cocaine given as a nasal spray immediately prior to nasal intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva analysis
Analysis of cocaine's main metabolite benzoylecgonine in saliva measured in nanograms per milliliter
Measured: 24 hours after cocaine administration
Secondary outcomes (1)
Whole blood toxicology
Analysis of cocaine in a whole blood sample measured in nanograms per milliliter
Measured: 1 hour and 24 hours after cocaine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start22 Mar 2023
- Primary completion27 May 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Haslund Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mo Haslund Larsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334056
- Sponsor's protocol ID
- 50510617
- Other IDs
- 2021-000709-26, H-21028055
- Status last verified
- May 2023
- First submitted
- 12 Apr 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Test Detection 24 Hours After Nasal Administration of Cocaine as a Local Vasoconstrictor Prior to Nasal Intubation
- ClinicalTrials.gov ID
- NCT05334056
- Acronym / sponsor ID
- 50510617
- Conditions
- Cocaine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- 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 objective of this study is to determine whether it is possible to detect traces above national cut-offs of either cocaine's main metabolite benzoylecgonine in saliva or cocaine in blood 24 hours after administering 2 ml of 40 mg/ml cocaine-saline to the nasal mucosa.
The investigators hypothesize that the level of cocaine's main metabolite bezoylecgonine in saliva after cocaine administered for anesthetic purposes will be below detection limits after 24 hours.
Detailed description
When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. Prior to nasal intubation the mucosa must be sufficiently lubricated and decongested in order to minimize epistaxis. When intubation is performed on awake patients anesthesia of the nose is also necessary. Cocaine has for many years been used for both decongestive and anesthetic purposes due to its unique pharmacodynamic profile. When applied to the nasal mucosa its vasoconstrictive quality aids in facilitating the inspection of the nasal cavity whilst the anesthetic effect allows for manipulation within the cavity. The vasoconstriction arises through cocaine's ability to inhibit the reuptake and metabolism of catecholamines, which then in greater concentration has adrenergic effects. By binding to and blocking axonal membrane sodium channels, cocaine interferes with the propagation of action potentials and thereby also exerts an analgesic effect.
Along with other countries Denmark has a legal zero tolerance policy for a long list of drugs in drivers including cocaine. During routine screenings or if the police suspect a driver to be under the influence of illegal drugs, they will first complete a qualitative saliva analysis testing for cocaine's main metabolite benzoyelecgonine. If the test comes out positive or there are clinical signs of drug influence, a supplementary blood sample measuring cocaine will be drawn and analyzed for use in the legal system. Repercussions from a cocaine test value exceeding the legal limit consists of a large fine, driver's license revocation and mandatory participation in a drug and alcohol course, neither of which seems fair to inflict on the uninformed and consequently unaware patient.
Pharmacokinetics for nasal cocaine have been described but no studies defining proper instructional driving precautions appear to exist. One study recommended patients be informed and consent prior to cocaine administration and be warned they may fail a drug test up to 72 hours postoperatively but as of 2021 patients are in many countries - including Denmark - still not informed about this time limit.
When administered in doses thought to avoid systemic effects, cocaine is a safe local anesthetic agent. The recommended dosage varies considerably throughout the literature with safe doses ranging between 1.5-3.0 mg/kg. The amount of cocaine absorbed has in one study been found to be 5% but has not been subsequently verified. The dosage of cocaine used prior to nasal intubation in Denmark is typically 1-2 ml of 4% cocaine resulting in a total dose of 40-80 mg. The typical 'street dose' is 40-100 mg. The Danish cut-off values for detection of cocaine's main metabolite benzoylecgonine is 200 ng/ml in saliva and 0.01 mg/kg in whole blood.
The investigators wish to evaluate whether cocaine levels exceed detection limits 24 hours after administration prior to nasal intubation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients schedualed to undergo surgery at Rigshospitalet with the use of nasal intubation.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Scheduled for nasal intubation
- Proficient in spoken and written Danish
- Negative baseline cocaine saliva test
Key exclusion criteria (8 listed)
- Intubation to be done on awake patient
- Pregnancy
- Known symptomatic coronary artery disease
- Untreated hypertension
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 |
|---|---|---|
| Cocaine NasalAlso: Cocaine 4%2 ml of 4% cocaine given as a nasal spray immediately prior to nasal intubation | Drug | – |
Primary outcome
Saliva analysis
Time frame: 24 hours after cocaine administration
Analysis of cocaine's main metabolite benzoylecgonine in saliva measured in nanograms per milliliter
1 secondary outcome
Whole blood toxicology
Time frame: 1 hour and 24 hours after cocaine administration
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 1 Jun 2023.
- Individual participant dataSharing planned: No
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.
Mo Haslund Larsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Adverse Reaction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 8 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 1 Jun 2023. 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 Denmark. 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.
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?
Saliva analysis (time frame: 24 hours after cocaine administration). 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 1 Jun 2023.