Conversion to Embeda With Rescue Trial (ConvERT)

A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion

The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.

Study Overview

• Status: Terminated
• Conditions: Pain; Chronic Disease
• Intervention / Treatment: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)

Detailed Description

The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.

• Study Type: Interventional
• Enrollment (Actual): 684
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Adamsville, Alabama, United States, 35005
      • Adamsville Family Medicine
    • Birmingham, Alabama, United States, 35209
      • Office of David McLain
    • Huntsville, Alabama, United States, 35801
      • Monte Sano Clinical Research, LLC
    • Huntsville, Alabama, United States, 35801
      • Tennessee Valley Pain Consultants Properties, LLC
    • Mobile, Alabama, United States, 36693
      • Sunbelt Research Group, Llc
    • Montgomery, Alabama, United States, 36117
      • Office of Vaughn H. Mancha, Jr., PC
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85029
      • Redpoint Research
    • Phoenix, Arizona, United States, 85020
      • Dedicated Clinical Research, Inc
    • Phoenix, Arizona, United States, 85032
      • Anasazi Internal Medicine, PC
    • Sierra Vista, Arizona, United States, 85635
      • Cochise Clinical Research
    • Tempe, Arizona, United States, 85282
      • Premiere Phamaceutical Research, LLC
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical and Research Center, LLC
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Ouachita Regional Pain Management
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Paragould, Arkansas, United States, 72450
      • Hollis Family Medical Clinic, PLC
  • California
    • Costa Mesa, California, United States, 92626
      • CSI Clinical Trials
    • Foothill Ranch, California, United States, 92610
      • Global Wellness Medical Corporation
    • Inglewood, California, United States, 90301
      • Chrishard Medical Group
    • La Mesa, California, United States, 91942
      • Triwest Research Associates LLC
    • Laguna Hills, California, United States, 92637
      • Pacific Coast Pain Management Center
    • Long Beach, California, United States, 90806
      • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
    • Los Angeles, California, United States, 90017
      • LA Pain & Wellness Institute
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research
    • Newport Beach, California, United States, 92663
      • Newport Beach Clinical Research Associates, Inc.
    • Paramount, California, United States, 90723
      • Bayview Research Group, LLC
    • Pasadena, California, United States, 91105
      • Pasadena Rehabilitation Institute
    • Roseville, California, United States, 95661
      • Quality Control Research, Inc.
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Sacramento, California, United States, 95842
      • Quality Control Research, Inc.
    • San Marcos, California, United States, 92078
      • Rancho Santa Fe Medical Group, Inc.
    • Santa Ana, California, United States, 92701
      • Trinity Clinical Trials
    • Santa Ana, California, United States, 92701
      • Probe Clinical Research Corporation
    • Upland, California, United States, 91786
      • Facility Medical Center
    • Valley Village, California, United States, 91607
      • Bayview Research Group, LLC
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Internal Medicine, PC
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
    • Fort Collins, Colorado, United States, 80525
      • Saint Luke's Medical Clinic, LLC
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • ProHealth Physicians PC
    • Milford, Connecticut, United States, 06460
      • Milford Physician Services, PC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute, LLC
    • Clearwater, Florida, United States, 33755
      • Florida Research & Testing, LLC
    • DeBary, Florida, United States, 32746
      • Omega Research Consultants, LLC
    • Debary, Florida, United States, 32713
      • Omega Research Consultants, LLC
    • Dunnellon, Florida, United States, 34432
      • West Florida Medical Associate, PA
    • Hialeah, Florida, United States, 33012
      • International Research Associates, LLC
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute, Inc
    • Kissimmee, Florida, United States, 34741
      • FPA Clinical Research, LLC
    • Lakeland, Florida, United States, 33810
      • Clinical Research of Central Florida, Inc.
    • Miami, Florida, United States, 33175
      • New Horizon Research Center, Inc.
    • Miami, Florida, United States, 33155
      • Community Research Foundation, Inc.
    • Miami Beach, Florida, United States, 33140
      • NextPhase Clinical Trials, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Harmony Clinical Research, Inc.
    • North Palm Beach, Florida, United States, 33408
      • Office of Laszlo J. Mate, MD, PA
    • Ocala, Florida, United States, 34474
      • Office of Richard E. Promin, MD, PA
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Centers, Inc.
    • Pompano Beach, Florida, United States, 33064
      • Pain Management Strategies, Inc.
    • Sarasota, Florida, United States, 34238
      • Sarasota Pain Medicine Research, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
    • Wellington, Florida, United States, 33414
      • Clinical Research Center, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Perimeter Institute for Clinical Research, Inc.
    • Columbus, Georgia, United States, 31909
      • Medical Research and Health Education Foundation, Inc.
    • Decatur, Georgia, United States, 30032
      • Ialum Clinical Research, LLC
    • Stone Mountain, Georgia, United States, 30088
      • Ialum Clinical Research, LLC
    • Suwanee, Georgia, United States, 30024
      • Herman Clinical Research, LLC
    • Tifton, Georgia, United States, 31794
      • Centers for Pain Management
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Chicago Clinical Research Institute Inc.
    • Creve Coeur, Illinois, United States, 61610
      • Creve Coeur Family Practice
    • Peoria, Illinois, United States, 61614
      • Office of Rebecca Knight, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Josephson Wallack Munshower Neurology P.C.
    • Michigan City, Indiana, United States, 46360
      • LaPorte County Institute for Clinical Research Inc.
    • Mishawaka, Indiana, United States, 46545
      • McKinley Research, LLC
    • South Bend, Indiana, United States, 46601
      • Accelovance, Inc.
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Des Moines Orthopaedic Surgeons, PC
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Pain Treatment Center of the Bluegrass
    • Louisville, Kentucky, United States, 40223
      • Healing Options
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Inc.
    • Russell Springs, Kentucky, United States, 42642
      • Lakewood Family Practice
  • Maryland
    • College Park, Maryland, United States, 20740
      • Diseasebusters, LLC
    • Pikesville, Maryland, United States, 21208
      • Office of Steven C. Miller, MD
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research, LLC
    • Fall River, Massachusetts, United States, 02720
      • Ronald J. Rapoport, MD, PC
    • Waltham, Massachusetts, United States, 02154
      • Boston Paincare Center, Inc.
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Clarkston Medical Group, PC
    • Flint, Michigan, United States, 48504
      • Apex Medical Research, AMR, Inc.
    • Flint, Michigan, United States, 48507
      • East Michigan Medical Associates
    • Lansing, Michigan, United States, 48910
      • PCM Medical Services, PC
    • Rochester, Michigan, United States, 48307
      • Remedica LLC
    • Sterling, Michigan, United States, 48314
      • Michigan Lifestyle Change and Health Center, PC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • MAPS Applied Research Center, Inc.
    • Shakopee, Minnesota, United States, 55379
      • MAPS Applied Research Center, Inc.
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Anesthesia and Pain Control Services
    • Jackson, Mississippi, United States, 39202
      • CRC of Jackson, LLC
    • Southhaven, Mississippi, United States, 38671
      • Midsouth Anesthesia Consultants, PLLC
  • Missouri
    • Florissant, Missouri, United States, 63031
      • Patterson Medical Clinic, Inc.
    • Florissant, Missouri, United States, 63033
      • Quality Clinical Research Inc.
    • Jefferson City, Missouri, United States, 65109
      • Primary Care Medicine, PC
  • Montana
    • Anaconda, Montana, United States, 59711
      • The Reiter Foundation, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Medical Pain Relief Clinic
    • Omaha, Nebraska, United States, 68116
      • Omaha Clinical Research, PC
  • New Jersey
    • Atco, New Jersey, United States, 08004
      • Atco Medical Associates, PC
    • Belvidere, New Jersey, United States, 07823
      • Office of John V. Bernard, MD
    • Elizabeth, New Jersey, United States, 07202
      • Central Jersey Medical Research Center, Inc.
    • Hackensack, New Jersey, United States, 07601
      • Center for Pain Management
    • Haddon Heights, New Jersey, United States, 08035
      • Advocare Heights Primary Care
    • Linden, New Jersey, United States, 07036
      • NJ Heart, LLC
    • Shrewsbury, New Jersey, United States, 07702
      • Spine and Pain Centers, PA
    • Trenton, New Jersey, United States, 08611
      • Premier Research, Inc.
  • New York
    • Glens Falls, New York, United States, 12801
      • Adirondack Medical Research Center
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group LLP
    • Hartsdale, New York, United States, 10530
      • Drug Trials America, Inc.
    • Long Beach, New York, United States, 11561
      • Office of Roger Kasendorf, DO
    • Mayville, New York, United States, 14757
      • Family Health Medical Services PLLC
    • North Syracuse, New York, United States, 13212
      • New York Spine & Wellness Center
    • Valley Stream, New York, United States, 11580
      • North American Partners in Pain Management, LLP
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Carolina Clinical Research and Consulting, LLC
    • Asheboro, North Carolina, United States, 27205
      • Carolina Clinical Research and Consulting, LLC
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute, Inc.
    • Hickory, North Carolina, United States, 28602
      • Catawba Valley Internal Medicine
    • Jacksonville, North Carolina, United States, 28546
      • Profen Research Network at ECMA
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Ohio
    • Carlisle, Ohio, United States, 45005
      • Medical Frontiers, LLC
    • Centerville, Ohio, United States, 45459
      • Valley Medical Research
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Center
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research Services
    • Delaware, Ohio, United States, 43015
      • Delaware Smith Clinic Research
    • Franklin, Ohio, United States, 45005
      • Medical Frontiers, LLC
    • New Lexington, Ohio, United States, 43764
      • Jeffrey J. Haggenjos, DO, Inc.
    • Perrysburg, Ohio, United States, 43551
      • Whole Family Medical Care LLC
    • Salem, Ohio, United States, 44460
      • Office of Jocelyn F. Shimek, DO
    • Tiffin, Ohio, United States, 44883
      • Office of James Lassiter
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Health Research Institute, LLC
    • Oklahoma City, Oklahoma, United States, 73109
      • Office of Siavash Nael, MD, Inc.
    • Stillwater, Oklahoma, United States, 74074
      • Associates of Medicine/John D. Williams, MD, PLLC
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Portland Rheumatology Clinic, Llc
    • Milwaukie, Oregon, United States, 97222
      • Office of Joseph E. Yankee, DO, PC
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
      • Pennsylvania Pain Specialists, PC
    • Aston, Pennsylvania, United States, 19014
      • Ware Medical Associates, PC
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research, PC
    • Harrisburg, Pennsylvania, United States, 17112
      • Kandra, Fierer, Kuskin Associates, Ltd.
    • Philadelphia, Pennsylvania, United States, 19152
      • Founders Research Corporation
    • Philadelphia, Pennsylvania, United States, 19104
      • Onuorah Umeh, M.D. P.C
    • Wind Gap, Pennsylvania, United States, 18091
      • Progressive Pain Solutions, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Hartwell Research Group, LLC
    • Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, Inc.
    • Greer, South Carolina, United States, 29650
      • Internal Medicine of Greer Research LLC
    • Murrells Inlet, South Carolina, United States, 29576
      • Clinical Research Authority, Llc
    • North Charleston, South Carolina, United States, 29406
      • Trident Institute of Medical Research, LLC
    • Orangeburg, South Carolina, United States, 29118
      • Low Country Pain Center, LLC
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Brown Clinic, PLLP
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
    • Hendersonville, Tennessee, United States, 37075
      • Comprehensive Pain Specialists
  • Texas
    • Corsicana, Texas, United States, 75110
      • Corsicana Medical Research, PLLC
    • Dallas, Texas, United States, 75254
      • DCT - Genesis Neighborhood Research, LLC
    • El Paso, Texas, United States, 79902
      • Southwest Urgent Care Center
    • Houston, Texas, United States, 77034
      • Accurate Clinical Research, Inc.
    • Houston, Texas, United States, 77005
      • Westbury Medical Clinic
    • Houston, Texas, United States, 77083
      • MedStar Clinical Research
    • San Antonio, Texas, United States, 78238
      • Texas Medical Research Associates, LLC
    • Waco, Texas, United States, 76710
      • Hillcrest Family Health Center, Division of Clinical Research
    • Waco, Texas, United States, 76710
      • Hillcrest Family Health Center
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research, LLC
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Sentara Medical Group, NDC Medical Center
  • Washington
    • Edmonds, Washington, United States, 98026
      • Washington Center for Pain Management PLLC
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Pain Care, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be able to read, speak and understand English
• Have chronic moderate to severe pain for at least 3 months
• Require around the clock opioid medication for the relief of pain
• Have been taking a daily opioid for at least 30 days prior to starting the study
• Be able to be safely switched to a different pain medication
• Be practicing acceptable birth control methods for female patients of childbearing potential
• Be willing to participate in the study and able to comply with study procedures

Exclusion Criteria:

• Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
• Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
• Be currently taking tramadol and/or extended release morphine products
• Have respiratory depression
• Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
• Have migraines as your main source of pain
• Have any form of bowel obstruction
• Be pregnant or breast feeding
• Have had 2 or more surgeries for low back pain
• Be planning a major surgery during the study
• Be staying in a hospital or nursing home
• Be planning to have steroid injections for your chronic pain during the study
• Have a life expectancy of less than 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: morphine sulfate and naltrexone hydrochloride (EMBEDA)	Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA); Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration to Titrate Participants to Stable Dose	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6
Number of Titration Steps to Achieve Stable Dose	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy	A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.	Baseline through Week 6
Percentage of Participants With Rescue Medications Usage During Titration	Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.	Baseline through Week 6
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)	BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.	Baseline, Visit 3 (up to Week 6)
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide	The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.	Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Aberrant Behaviors	Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = 'never' and 4 = 'very often']. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.	Day 5
Number of Participants With Abnormal Urine Drug Test Results	Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.	Baseline, Visit 3 (up to Week 6)
Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids	Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.	Visit 3 (up to Week 6)
Number of Participants With Urine Drug Test Results Positive for Illicit Substances	Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.	Baseline, Visit 3 (up to Week 6)
Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid	Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.	Baseline, Visit 3 (up to Week 6)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Setnik B, Roland CL, Pixton GC, Sommerville KW. Prescription opioid abuse and misuse: gap between primary-care investigator assessment and actual extent of these behaviors among patients with chronic pain. Postgrad Med. 2017 Jan;129(1):5-11. doi: 10.1080/00325481.2017.1245585. Epub 2016 Oct 26.
• Setnik B, Roland CL, Sommerville KW, Pixton GC, Berke R, Calkins A, Goli V. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide. J Pain Res. 2015 Jul 8;8:347-60. doi: 10.2147/JPR.S82395. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: chronic pain; opioid; morphine; moderate pain; Embeda; severe pain; conversion; converting; switching; aberrant behavior; Pain (DT) + Chronic Disease (DT)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Morphine
• Other Study ID Numbers: ALO-01-10-4003; B4541001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No