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

• ClinicalTrials.gov Identifier: NCT01021176
• Recruitment Status: Terminated
• First Posted: November 26, 2009
• Last Update Posted: December 18, 2015
• Sponsor: Pennington Biomedical Research Center
• Collaborator: Compellis Pharmaceuticals
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Food Intake	Other: Placebo spray; Drug: Diltiazem	Phase 1

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 0mg 0 spray; No Diltiazem	Other: Placebo spray; 0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered; Other Name: Placebo
Active Comparator: 2mg 2 Spray; 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; 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.; Other Name: 5.5, 6.0, 6.3 and/or one more randomly
Active Comparator: 4mg 4 Spray; 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; 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.; Other Name: 5.5, 6.0, 6.3 and/or one more randomly
Active Comparator: 8mg 8 spray; 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; 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.; Other Name: 5.5, 6.0, 6.3 and/or one more randomly

Outcome Measures

Primary Outcome Measures :

1. Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray. [ Time Frame: 3 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Compellis Pharmaceuticals

Investigators

• Principal Investigator: Frank L. Greenway, MD; Pennington Biomedical Research Center

More Information

• Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT01021176
• Other Study ID Numbers: PBRC 27016
• First Posted: November 26, 2009
• Last Update Posted: December 18, 2015
• Last Verified: December 2015

Keywords provided by Frank Greenway, Pennington Biomedical Research Center:

Food Intake; Hunger; Lidocaine; Nose; smell

Additional relevant MeSH terms:

Diltiazem; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents