Skip to content

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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021176
Enrollment
12
Registered
2009-11-26
Start date
2009-10-31
Completion date
2009-11-30
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Intake

Keywords

Food Intake, Hunger, Lidocaine, Nose, smell

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.

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.

Interventions

0, 30, 60, 90, 120, 180, and 240 minutes following the nasal spray yet no drug will be administered

DRUGDiltiazem

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.

Sponsors

Compellis Pharmaceuticals
CollaboratorUNKNOWN
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026