Analysis of Atropine and Propranolol Induced Changes

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Atropine; Drug: Normal Saline; Drug: Propranolol

• Registration Number: NCT00251602
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	Normal Saline	II ACE genotype
5	Normal Saline	ID ACE genotype
6	Normal Saline	DD ACE genotype
1	Propranolol	II ACE genotype
2	Atropine	ID ACE genotype
1	Atropine	II ACE genotype
2	Propranolol	ID ACE genotype
3	Atropine	DD ACE genotype
3	Propranolol	DD ACE genotype
4	Propranolol	II ACE genotype
5	Propranolol	ID ACE genotype
6	Propranolol	DD ACE genotype

Primary Outcome Measures

Name	Time	Method
Changes in heart rate and blood pressure	every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time

Trial Locations

Locations (1)

National Institute on Aging, Harbor Hospital; 🇺🇸 Baltimore, Maryland, United States