Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray which will then reduce food intake.

Detailed Description
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You will fast on your first visit. Complete questionnaire about taste and smell to insure you don't have a cold or anything that would interfere with sense of smell. Your nose will be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg or a placebo. Your sense of smell will be tested at different time points.

Official Title
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A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem

Conditions
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Food Intake

Intervention / Treatment
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* Other: Placebo spray
* Drug: Diltiazem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 25 and 40 kg Blood pressure in within normal range Exclusion Criteria: Used tobacco products in the past month Used a calcium channel blocker medication in the last month used nasal sprays in the last month have an abnormal sense of smell or abnormalities of the lining in your nose female and have irregular menstrual periods female and are nursing a baby or pregnant female and have had a partial hysterectomy (still have ovaries)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0mg 0 spray<br>No Diltiazem | Other: Placebo spray<br>* 0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered<br>* Other names: Placebo;|
| Active Comparator: 2mg 2 Spray<br>Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 2mg/2 spray Diltiazem | Drug: Diltiazem<br>* 0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.<br>* Other names: 5.5, 6.0, 6.3 and/or one more randomly;|
| Active Comparator: 4mg 4 Spray<br>Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 4mg/4 spray Diltiazem | Drug: Diltiazem<br>* 0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.<br>* Other names: 5.5, 6.0, 6.3 and/or one more randomly;|
| Active Comparator: 8mg 8 spray<br>Staff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 8mg/8 spray Diltiazem | Drug: Diltiazem<br>* 0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray Three Dilutions would be 5.5, 6.0 and 6.3 and the fourth at the filp of a coin randomly diluted.<br>* Other names: 5.5, 6.0, 6.3 and/or one more randomly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray. |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Intake, Hunger, Lidocaine, Nose, smell