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Taste Acuity and Caloric Intake After Acute Morphine Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763697
First Posted: January 9, 2013
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Denis Antoine, Johns Hopkins University
  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 (Participant, 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 Denis Antoine, Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763697


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Denis G Antoine, M.D. Johns Hopkins University
  More Information

Responsible Party: Denis Antoine, Instructor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01763697     History of Changes
Other Study ID Numbers: NA_00046407
K24DA023186-06 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2013
First Posted: January 9, 2013
Last Update Posted: May 29, 2014
Last Verified: May 2014

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

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