Mild to Heavy Alcohol ConsumptionCAAPNCT02945293
Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
An observational study of Mild to Heavy Alcohol Consumption, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild to Heavy Alcohol Consumption
- What is being tested?
- Oxycodone
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 1 Sep 2021
- Phase
- Observational
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis
Who may be able to join
- Age of 35 years old or above
- Mild to moderate pain
- alcohol consumption
- willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana
- Cigarette smokers must be willing to refrain from smoking during the all day study visit
Who cannot join
- current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)
- abstains from alcohol
- unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment
- Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication
- History of recreational drug use in the past 1 year, excluding marijuana
- New or increased dose (within last 6 months) of CNS-active medications that may alter neurocognitive and/or psychomotor function: MAO inhibitors, neuroleptics, antidepressants, anticonvulsants, benzodiazepines, sleep aids
Show all 9Show fewer
- Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin
- Known hypersensitivity to oxycodone and other opioids;
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ. of Washington Medical Center
Seattle, Washington, 98195
About this study
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
Read the detailed description
Potential participants complete a phone screen. If still found eligible, the participant comes in for 1 screening visit (3 hours long). Cognitive/problem solving tests, computerized tasks, CPT, questionnaires and functional measures are administered along with a screening blood lab. If a participant is eligible, he/she comes back for 1 full study day visit (9-10 hours long). A testing battery (similar to the one done during the screening visit) is completed at baseline and again at three timepoints following medication administration. Blood draws, vital signs, and pupil measurements are taken throughout the day. A follow-up phone call is completed within a few days of the full study day visit, during which a questionnaire is given.
- Conditions
- Mild to Heavy Alcohol Consumption
- Being tested
- Oxycodone
- Keywords
- Pain, Elderly, Aged, Opioid, Cognition, Side-effects, Alcohol, Alcohol Use Disorder (AUD), Older
- Medical subject headings
- Pain, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneOther
This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed
| Study group | Role | What they receive |
|---|---|---|
| Study Procedures | Study procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day. Receives: Other: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to a pain stimulus
Exposure to cold water, followed by exposure to warm water
Measured: given during study day
Secondary outcomes (4)
medication impact , opioid adjective checklist
adjective questionnaire on the impact of study medication scale of 0 t0 4 on likert scale
Measured: Study day visit (9-10 hours long)
functional measure of balance modified berg balance test
score on a functional questionnaire (0 - 30)
Measured: Screening visit (3 hours long) and study day visit (9-10 hours long)
Pupil size
measure of pupil diameter in millimeters
Measured: Study day visit (9-10 hours long)
verbal memory performance on list learning task
immediate and delayed recall of a list of words (score of 0 - 45)
Measured: Study day visit (9-10 hours long)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startNov 2015
- Primary completion1 Oct 2019
- Study completion1 Sep 2021 (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 Mild to Heavy Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Seattle Institute for Biomedical and Clinical Research
- Responsible party
- Principal investigator, Monique Cherrier, University of Washington
- Investigators
- Monique M. Cherrier, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945293
- Sponsor's protocol ID
- STUDY00001018
- Other IDs
- 5R01AG047979
- Acronym
- CAAP
- Status last verified
- May 2021
- First submitted
- 18 Oct 2016
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: For data obtained at UofW- a de-identified version can be made available upon request for data obtained at VAPSHCS IRB ISO, and PO do not allow the sharing of data, even de-identified data with other investigators- if VA regulations allow data sharing, then the investigators will be allowed to share data
Publications
Cherrier MM, Amory JK, Ersek M, Risler L, Shen DD. Comparative cognitive and subjective side effects of immediate-release oxycodone in healthy middle-aged and older adults. J Pain. 2009 Oct;10(10):1038-50. doi: 10.1016/j.jpain.2009.03.017. Epub 2009 Sep 2.
PubMed 19729346
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users
- ClinicalTrials.gov ID
- NCT02945293
- Acronym / sponsor ID
- CAAP / STUDY00001018
- Conditions
- Mild to Heavy Alcohol Consumption
- Keywords
- Pain, Elderly, Aged, Opioid, Cognition, Side-effects, Alcohol, Alcohol Use Disorder (AUD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Seattle Institute for Biomedical and Clinical Research
- Study start
- Nov 2015 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 Oct 2016 (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.
The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.
Detailed description
Potential participants complete a phone screen. If still found eligible, the participant comes in for 1 screening visit (3 hours long). Cognitive/problem solving tests, computerized tasks, CPT, questionnaires and functional measures are administered along with a screening blood lab. If a participant is eligible, he/she comes back for 1 full study day visit (9-10 hours long). A testing battery (similar to the one done during the screening visit) is completed at baseline and again at three timepoints following medication administration. Blood draws, vital signs, and pupil measurements are taken throughout the day. A follow-up phone call is completed within a few days of the full study day visit, during which a questionnaire is given.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Procedures | – | Other: OxycodoneStudy procedures include a screening visit, a study day visit, and a follow-up phone call. Oxycodone is administered on the study day. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community dwelling participants in the greater Puget Sound region (Seattle and Tacoma) who consume alcohol on a frequent basis
Key inclusion criteria (5 listed)
- Age of 35 years old or above
- Mild to moderate pain
- alcohol consumption
- willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana
- Cigarette smokers must be willing to refrain from smoking during the all day study visit
Key exclusion criteria (9 listed)
- current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)
- abstains from alcohol
- unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment
- Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication
- History of recreational drug use in the past 1 year, excluding marijuana
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 |
|---|---|---|
| OxycodoneThis study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed | Other | Study Procedures |
Primary outcome
response to a pain stimulus
Time frame: given during study day
Exposure to cold water, followed by exposure to warm water
4 secondary outcomes
medication impact , opioid adjective checklist
Time frame: Study day visit (9-10 hours long)
functional measure of balance modified berg balance test
Time frame: Screening visit (3 hours long) and study day visit (9-10 hours long)
Pupil size
Time frame: Study day visit (9-10 hours long)
verbal memory performance on list learning task
Time frame: Study day visit (9-10 hours long)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Background: PubMed 19729346Cherrier MM, Amory JK, Ersek M, Risler L, Shen DD. Comparative cognitive and subjective side effects of immediate-release oxycodone in healthy middle-aged and older adults. J Pain. 2009 Oct;10(10):1038-50. doi: 10.1016/j.jpain.2009.03.017. Epub 2009 Sep 2.
- Individual participant dataSharing planned: Yes. For data obtained at UofW- a de-identified version can be made available upon request for data obtained at VAPSHCS IRB ISO, and PO do not allow the sharing of data, even de-identified data with other investigators- if VA regulations allow data sharing, then the investigators will be allowed to share data
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.
Monique M. Cherrier, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Heavy Alcohol Consumption, run by University of Washington 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 5 inclusion and 9 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 13 May 2021. 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. 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?
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?
response to a pain stimulus (time frame: given during study day). 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 NCT02945293, 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 13 May 2021.