Taste SweetNCT01763697
Taste Acuity and Caloric Intake After Acute Morphine Administration
A study testing taste acuity assessment and Recorded meal in people with Taste Sweet and Taste Salty, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Taste Sweet, Taste Salty, Feeding Behavior
- What is being tested?
- taste acuity assessment and Recorded meal
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male and female volunteers
- Ages of 18 to 65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
- Conditions
- Taste Sweet, Taste Salty, Feeding Behavior
- Being tested
- taste acuity assessment, Recorded meal
- Keywords
- Taste acuity, Feeding behavior, opioid, Quantitative assessment
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taste acuity assessmentBehavioural
Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
Recorded mealBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Morhpine/Taste acuity | Active comparator | Taste acuity assessment after 1mg subcutaneous morphine injection Receives: Behavioral: taste acuity assessment; Behavioral: Recorded meal |
| Placebo/Taste acuity | Placebo comparator | Taste acuity assessment after subcutaneous placebo injection Receives: Behavioral: taste acuity assessment; Behavioral: Recorded meal |
| Morphine4/Taste acuity | Active comparator | Taste acuity assessment after 4mg subcutaneous morphine injection Receives: Behavioral: taste acuity assessment; Behavioral: Recorded meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste
The primary outcome variable will be the taste acuity profile, which includes the taste detection threshold, recognition threshold, magnitude estimation, and hedonic response.
Measured: 3 hours after dose administration
Secondary outcomes (1)
Calories
The secondary outcome measure will be the amount of calories consumed over a 2 hours period following the drug administration.
Measured: 6 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste SweetStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Denis Antoine, Johns Hopkins University
- Investigators
- Denis G Antoine, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763697
- Sponsor's protocol ID
- NA_00046407
- Other IDs
- K24DA023186-06
- Status last verified
- May 2014
- First submitted
- 7 Jan 2013
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Acuity and Caloric Intake After Acute Morphine Administration
- ClinicalTrials.gov ID
- NCT01763697
- Acronym / sponsor ID
- NA_00046407
- Conditions
- Taste Sweet, Taste Salty, Feeding Behavior
- Keywords
- Taste acuity, Feeding behavior, opioid, Quantitative assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morhpine/Taste acuity | Active comparator | Behavioral: taste acuity assessment, Behavioral: Recorded mealTaste acuity assessment after 1mg subcutaneous morphine injection |
| Placebo/Taste acuity | Placebo comparator | Behavioral: taste acuity assessment, Behavioral: Recorded mealTaste acuity assessment after subcutaneous placebo injection |
| Morphine4/Taste acuity | Active comparator | Behavioral: taste acuity assessment, Behavioral: Recorded mealTaste acuity assessment after 4mg subcutaneous morphine injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult male and female volunteers
- Ages of 18 to 65
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taste acuity assessmentQuantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response. | Behavioural | Morhpine/Taste acuity, Morphine4/Taste acuity, Placebo/Taste acuity |
| Recorded meal | Behavioural | Morhpine/Taste acuity, Morphine4/Taste acuity, Placebo/Taste acuity |
Primary outcome
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.
1 secondary outcome
Calories
Time frame: 6 hours after dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Related trials for Taste Sweet
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Enrolling by invitation
This Trial Aims to Assess the Effects of Three Different Taste-based Dietary Recommendations for Reducing Free Sugar Intakes on Free Sugar Consumption in UK High Free Sugar Consumers
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RecruitingObservational study
Abnormal Eating and Taste Perception in Subjects With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis G Antoine, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taste acuity assessment and Recorded meal in people with Taste Sweet and Taste Salty, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste (time frame: 3 hours after dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.