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Taste Acuity and Caloric Intake After Acute Morphine Administration

This study is currently recruiting participants.
Verified March 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Denis Antoine, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01763697
First received: January 7, 2013
Last updated: March 16, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Taste Sweet
Taste Salty
Feeding Behavior
Behavioral: taste acuity assessment
Behavioral: Recorded meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Taste Acuity and Caloric Intake After Acute Morphine Administration

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Taste [ Time Frame: 3 hours after dose administration ] [ Designated as safety issue: No ]
    The primary outcome variable will be the taste acuity profile, which includes the taste detection threshold, recognition threshold, magnitude estimation, and hedonic response.


Secondary Outcome Measures:
  • Calories [ Time Frame: 6 hours after dose administration ] [ Designated as safety issue: No ]
    The secondary outcome measure will be the amount of calories consumed over a 2 hours period following the drug administration.


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763697

Contacts
Contact: Denis G Antoine, M.D. 410-550-2796 antoine@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Denis Antoine, M.D.       antoine@jhmi.edu   
Principal Investigator: Denis Antoine, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Denis G Antoine, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Denis Antoine, Instructor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01763697     History of Changes
Other Study ID Numbers: NA_00046407, K24DA023186-06
Study First Received: January 7, 2013
Last Updated: March 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Taste acuity
Feeding behavior
opioid
Quantitative assessment

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014