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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01763697
Other study ID # NA_00046407
Secondary ID K24DA023186-06
Status Completed
Phase N/A
First received January 7, 2013
Last updated May 28, 2014
Start date March 2013
Est. completion date May 2014

Study information

Verified date May 2014
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
taste acuity assessment
Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Recorded meal


Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Taste 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 No
Secondary Calories 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 No
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