Cognitive DysfunctionNCT02226601
Aprepitant to Mitigate Opioids' Cognitive Side Effects
A study testing Aprepitant in people with Cognitive Dysfunction, run by University of Arizona at 1 site in United States.
Trial summary
Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2016
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy English speaking, opioid-naive consenting adults
Who cannot join
- current or very recent (< 3 months) opioid therapy
- morbid obesity
- liver disease
- therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
- acute or chronic infections
- immunocompromised status
Show all 11Show fewer
- hemodynamically unstable, hemorrhage (bleeding)
- recent surgery
- pregnancy, nursing
- younger than 18 years old
- not proficient of the English language
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona Medical Center
Tucson, Arizona, 85724
Kai Schoenhage, MD
About this study
Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.
Read the detailed description
In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and feeling "high".
This would allow for a better recovery period, in which patients can be more "themselves", participate in activities around them and move forward.
Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter.
A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.
- Conditions
- Cognitive Dysfunction
- Being tested
- Aprepitant, Placebo
- Keywords
- drowsiness, loopiness, nausea
- Medical subject headings
- Cognitive Dysfunction, Sleepiness, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
3 days perioperative Aprepitant once a day
PlaceboDrug
3 days perioperative Placebot once a day
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Active comparator | Aprepitant
* 40 mg IV pre-operatively
* 40 mg PO post-op day #1
* 40 mg PO post-op day #2 Receives: Drug: Aprepitant |
| Placebo | Placebo comparator | * electrolyte (0.9% NaCl) infusion) pre-operatively
* capsule without medication on post-op day #1
* capsule without medication on post-op day #2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
questionnaires
Measured: 3 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Schoenhage, University of Arizona
- Investigators
- Kai Schoenhage, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226601
- Sponsor's protocol ID
- CognAp
- Status last verified
- May 2015
- First submitted
- 21 Aug 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
PubMed 22260216
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant to Mitigate Opioids' Cognitive Side Effects
- ClinicalTrials.gov ID
- NCT02226601
- Acronym / sponsor ID
- CognAp
- Conditions
- Cognitive Dysfunction
- Keywords
- drowsiness, loopiness, nausea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 27 Aug 2014 (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.
Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.
Detailed description
In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and feeling "high".
This would allow for a better recovery period, in which patients can be more "themselves", participate in activities around them and move forward.
Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter.
A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Active comparator | Drug: AprepitantAprepitant * 40 mg IV pre-operatively * 40 mg PO post-op day #1 * 40 mg PO post-op day #2 |
| Placebo | Placebo comparator | Drug: Placebo* electrolyte (0.9% NaCl) infusion) pre-operatively * capsule without medication on post-op day #1 * capsule without medication on post-op day #2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy English speaking, opioid-naive consenting adults
Key exclusion criteria (11 listed)
- current or very recent (< 3 months) opioid therapy
- morbid obesity
- liver disease
- therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
- acute or chronic infections
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 |
|---|---|---|
| AprepitantAlso: Emend3 days perioperative Aprepitant once a day | Drug | Aprepitant |
| Placebo3 days perioperative Placebot once a day | Drug | Placebo |
Primary outcome
cognitive function
Time frame: 3 days post-operatively
questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Background: PubMed 22260216Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
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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.
Kai Schoenhage, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant in people with Cognitive Dysfunction, run by University of Arizona 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Schoenhage, MD (5206260373, kschoenhage@anesth.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: 3 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226601, which also lists 1 linked publication.
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 2 Jun 2015.