Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2021-09-01

Brief Summary

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The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.

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Detailed Description

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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

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Mild to Heavy Alcohol Consumption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Oxycodone

Intervention Type OTHER

This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed

Interventions

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Oxycodone

This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin
* Known hypersensitivity to oxycodone and other opioids;
* Pregnancy

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes