The extent and rate of atropine sulfate absorption when administered under the tongue in humans
- Conditions
- HypersalivationDroolingMental Health - Schizophrenia
- Registration Number
- ACTRN12618001817235
- Lead Sponsor
- Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Healthy Participants:
1.Age: between 18 and 50 year old
2.Non pregnant or breast feeding
3.Able to consent for participation in the study
4. Healthy as per the pathology test results, ECG, and medical history.
Clozapine-treated patients:
1.Age: between 18 and 50 year old
2.Non pregnant or breast feeding
3.Able to consent for participation in the study
4. Treated with clozapine.
Healthy Participants:
1.Known allergy to atropine
2.Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
3.Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
4.Known to have or found upon screening to have high blood pressure ( more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
5.Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
6.Have dry mouth, hypersalivation or drooling.
7.Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
8.Treated with a medication that has an anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
9.Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
Clozapine treated participants:
Known to have any of the following conditions:
1. Known allergy to atropine
2. Females during the menstrual period
3. Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
4. Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
5. Known to have or found upon screening to have high blood pressure (more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
6. Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
7. Have severe constipation or diarrhoea.
8. Have dry mouth, hypersalivation or drooling.
9. Wearing dental braces
10. Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
11. Is treated with any medication other than clozapine that is known to have a significant anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
12. Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time needed for the atropine sulfate to be detected in the venous blood as assessed by serial blood collection.[Immediately prior to the administration of the study medication then 5, 10, 20, 30, 40, and 60 minutes and at 2, 3, 6, 8, 9, 10 hours post administration]
- Secondary Outcome Measures
Name Time Method Pulse rate as assessed by sphygnamometer[The pulse rate will be checked at baselines and then every 15 minutes over the first one hour then every 30 minutes over following one hour after the administration of the study medication. ];Amount of saliva secreted over 5 minutes. Cotton rolls and saliva pads will be used to measure the saliva amount secreted.[Saliva secretion will be measured at baselines and 2 hours after the administration of the study medication]