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Analysis of Atropine and Propranolol Induced Changes

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Propranolol
Drug: Normal Saline
Drug: Atropine

Study type

Interventional

Funder types

NIH

Identifiers

Details and patient eligibility

About

The purpose of this study is to learn the effects of genetic make up on response to the drugs atropine and propranolol, to examine how changes in heart rate and blood pressure can be measured, and to test a new statistical analysis method.

Full description

Healthy volunteers will be recruited and screened for eligibility. Participants will be placed into three possible groups based on genetic information obtained during screening. Rolling admissions will continue until at least 10 participants have been recruited for each genetic group. Participants will be randomly assigned to receive either the control (propranolol and saline) or combined drug (propranolol and atropine) treatment in a non-blinded fashion. The participant will return over one week later to receive the alternate treatment. Continuous heart rate/blood pressure data will be recorded until the end of the study period. Respiratory rate will be maintained at a fixed rate. Participants will undergo an orthostasis task, receive the drug or control infusions, and blood samples will then be obtained to determine drug concentrations at specific time intervals. Several relatively new mathematical techniques will be applied to the data.

Enrollment

24 patients

Sex

All

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and female volunteers
  • Ages 21-40
  • Body Mass Index >18.0 and <27.0

Exclusion criteria

  • History of any chronic illnesses including cardiac diseases and bleeding problems
  • Drug use of any kind
  • Participation in any clinical trial within the last month
  • Tobacco use and/or alcohol abuse
  • Use of dietary supplements and unwillingness to refrain

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 6 patient groups, including a placebo group

1
Experimental group
Description:
II ACE genotype
Treatment:
Drug: Atropine
Drug: Propranolol
2
Experimental group
Description:
ID ACE genotype
Treatment:
Drug: Atropine
Drug: Propranolol
3
Experimental group
Description:
DD ACE genotype
Treatment:
Drug: Atropine
Drug: Propranolol
4
Placebo Comparator group
Description:
II ACE genotype
Treatment:
Drug: Normal Saline
Drug: Propranolol
5
Placebo Comparator group
Description:
ID ACE genotype
Treatment:
Drug: Normal Saline
Drug: Propranolol
6
Placebo Comparator group
Description:
DD ACE genotype
Treatment:
Drug: Normal Saline
Drug: Propranolol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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