Taste Acuity and Caloric Intake After Acute Morphine Administration

May 28, 2014 updated by: Denis Antoine, Johns Hopkins University
This study will investigate the effects of acute morphine administration on taste acuity and how much a person eats. It is hypothesized that there will be a dose dependent decrease in taste acuity and dose dependent increase in food intake associated with acute morphine administration. Knowledge from this study will impact the future of feeding behavior and obesity research in the general population. Results will also promote exploration of the long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult male and female volunteers
  • Ages of 18 to 65

Exclusion Criteria:

  • History of drug dependence (including opioid use disorders)
  • History of taste dysfunction
  • Significant medical or Axis I psychiatric disorder
  • Any trauma or surgical procedures to the head or neck region
  • Medication or illicit drug more than 4 out of the last 30 days.
  • Pregnancy
  • Abnormal electrocardiogram findings
  • Negative rating of greater than 40% of the foods available for consumption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Morhpine/Taste acuity
Taste acuity assessment after 1mg subcutaneous morphine injection
Behavioral: taste acuity assessment
Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Behavioral: Recorded meal
Placebo Comparator: Placebo/Taste acuity
Taste acuity assessment after subcutaneous placebo injection
Behavioral: taste acuity assessment
Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Behavioral: Recorded meal
Active Comparator: Morphine4/Taste acuity
Taste acuity assessment after 4mg subcutaneous morphine injection
Behavioral: taste acuity assessment
Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Behavioral: Recorded meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste
Time Frame: 3 hours after dose administration
The primary outcome variable will be the taste acuity profile, which includes the taste detection threshold, recognition threshold, magnitude estimation, and hedonic response.
3 hours after dose administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calories
Time Frame: 6 hours after dose administration
The secondary outcome measure will be the amount of calories consumed over a 2 hours period following the drug administration.
6 hours after dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Denis G Antoine, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00046407
  • K24DA023186-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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