Back to resultsEffect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxymorphone ER
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring opioid tolerant, chronic pain
Eligibility Criteria
Inclusion Criteria:
- Man or woman, 18-65 years of age, inclusive
- Able to provide informed consent and comply with all study procedures
- Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
- Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
- Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
- Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
- Weight at screening 100-300 pounds, inclusive
Exclusion Criteria:
- Pregnant or breastfeeding
- Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
- Alcohol or substance abuse within 2 years of screening
- Consumption of alcohol within 24 hours of a screening or testing visit
- Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
- Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
- Epworth sleepiness scale (ESS) score 16 or higher at screening
- Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
- Any clinically significant illness that would interfere with study participation or put the subject at risk
- Exposure to investigational medication within 30 days of screening
Sites / Locations
- MedVadis Research Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxymorphone ER 40 mg fed
Oxymorphone ER 40 mg fasting
Arm Description
Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal
Participants received 40 mg oxymorphone ER after fasting for 8-12 hours
Outcomes
Primary Outcome Measures
Rapid Visual Information Processing (RVP) Sensitivity [A']
RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]).
Rapid Visual Information Processing (RVP) Response Latency
RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]).
Secondary Outcome Measures
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits
SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]).
Spatial Recognition Memory (SRM) Test Response Latency
SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]).
Spatial Working Memory (SWM) Test Total Errors
SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (strategy score).
Spatial Working Memory (SWM) Test Strategy Score
SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (For assessed problems with six boxes or more, the number of distinct boxes used by the subject to begin a new search for a token)
Full Information
NCT ID
NCT00930943
First Posted
June 29, 2009
Last Updated
May 8, 2023
Sponsor
MedVadis Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00930943
Brief Title
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Official Title
Effect of Extended-release Oxymorphone Hydrochloride (Opana® ER), Taken Fasting Versus With Food, on Cognitive Functioning in Opioid-tolerant Subjects: a Randomized, Single-blinded, Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedVadis Research Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.
Detailed Description
Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
opioid tolerant, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxymorphone ER 40 mg fed
Arm Type
Experimental
Arm Description
Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal
Arm Title
Oxymorphone ER 40 mg fasting
Arm Type
Experimental
Arm Description
Participants received 40 mg oxymorphone ER after fasting for 8-12 hours
Intervention Type
Drug
Intervention Name(s)
Oxymorphone ER
Other Intervention Name(s)
Opana ER
Intervention Description
40 mg qd twice
Primary Outcome Measure Information:
Title
Rapid Visual Information Processing (RVP) Sensitivity [A']
Description
RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]).
Time Frame
1 and 3 hours postdose
Title
Rapid Visual Information Processing (RVP) Response Latency
Description
RVP is a test of sustained attention. It is a sensitive measure of general cognitive performance. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudorandom order, at the rate of 100 digits per minute. The subject is requested to detect target sequences of three digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the response box. The two main outcome measures are the probability to detect the predefined sequence (sensitivity [A']) and the speed at which the sequence is registered (response latency [ms]).
Time Frame
1 and 3 hours postdose
Secondary Outcome Measure Information:
Title
Spatial Recognition Memory (SRM) Test Percentage of Correct Hits
Description
SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]).
Time Frame
1 and 3 hours postdose
Title
Spatial Recognition Memory (SRM) Test Response Latency
Description
SRM tests visual spatial recognition memory in a two-choice forced discrimination paradigm. The subject is presented with a white square, which appears in sequence at five different locations on the screen. In the recognition phase, the subject sees a series of five pairs of squares, one of which is in a place previously seen in the presentation phase. The other square is in a location not seen in the presentation phase. Locations are tested in the reverse of the presentation order. The two main outcome measures are the percentage of correct trials (correct hits [%]) and the speed of the subject's response (response latency [ms]).
Time Frame
1 and 3 hours postdose
Title
Spatial Working Memory (SWM) Test Total Errors
Description
SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (strategy score).
Time Frame
1 and 3 hours postdose
Title
Spatial Working Memory (SWM) Test Strategy Score
Description
SWM is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. The test is a sensitive measure of executive function. It begins with a number of colored squares (boxes) being shown on the screen. By touching the boxes and using a process of elimination, the subject finds blue tokens in a number of boxes and uses them to fill up an empty column on the screen. The number of boxes is gradually increased, until it is necessary to search a total of eight boxes. The color and position of the boxes are changed from trial to trial to discourage the use of stereotyped search strategies. The two main outcome measures are errors (touching boxes that have been found to be empty and revisiting boxes that have already been found to contain a token - total errors) and a measure of strategy (For assessed problems with six boxes or more, the number of distinct boxes used by the subject to begin a new search for a token)
Time Frame
1 and 3 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or woman, 18-65 years of age, inclusive
Able to provide informed consent and comply with all study procedures
Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS (Morphine Sulfate) Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
Weight at screening 100-300 pounds, inclusive
Exclusion Criteria:
Pregnant or breastfeeding
Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
Alcohol or substance abuse within 2 years of screening
Consumption of alcohol within 24 hours of a screening or testing visit
Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
Epworth sleepiness scale (ESS) score 16 or higher at screening
Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
Any clinically significant illness that would interfere with study participation or put the subject at risk
Exposure to investigational medication within 30 days of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egilius LH Spierings, MD, PhD
Organizational Affiliation
MedVadis Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24330343
Citation
Spierings EL, Volkerts ER, Heitland I, Thomson H. A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects. Pain Med. 2014 Feb;15(2):264-71. doi: 10.1111/pme.12307. Epub 2013 Dec 11.
Results Reference
result
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Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
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