Clinical trial NCT00640042: Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
Official title: AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
opioid
abuse
moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 1570
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Detailed description: Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.

Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.

This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.

Eligibility criteria: Inclusion Criteria:

* Patient is an adult (greater than or equal to 21 years old
* Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at the discretion of the Investigator, requires an around-the-clock opioid for optimal analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an 11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable side effects to sustained release opioids or short-acting opioids.
* Patient is able to read and understand English and comply with protocol requirements.

Exclusion Criteria:

A patient who meets ANY of the following exclusion criteria will not be enrolled:

* Hypersensitivity to morphine, morphine salts, or any components of AVINZA
* Respiratory depression (slowed breathing)
* Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
* Currently has or is suspected of having paralytic ileus
* Requires a daily dose of AVINZA greater than 1600mg/day
* Patient is abusing alcohol
* Pregnancy or breast feeding
* Currently taking AVINZA
* Patient unwilling to sign the Treatment Agreement
* Life expectancy is less than 2 months
* Migraine as the primary pain score
* Patient resides in a hospital or nursing home
* Patient has had more than 2 surgeries for low back pain
* Patient is anticipated to require major surgery or steroid injections for chronic pain over the next 12 weeks

Primary outcomes:
measure: Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)
timeFrame: Baseline (Week 0) to Visit 3 (Week 6)
measure: Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)
timeFrame: Baseline (Week 0) to Visit 4 (Week 10)
measure: Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)
timeFrame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study)
measure: Number of Subjects With Treatment Emergent Adverse Events
timeFrame: Up to 4 months
measure: Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
timeFrame: Visit 3 (Week 6)
measure: Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
timeFrame: Visit 4 (Week 10)
Secondary outcomes:
measure: Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.
timeFrame: Up to 4 months
measure: Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.
timeFrame: 3 months post study
measure: Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.
timeFrame: 6 months post study
Other outcomes:
Locations:
city: Adamsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Sun Lakes
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Burlingame
country: United States
state: California
city: Castro Valley
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Hemet
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Livermore
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Murrieta
country: United States
state: California
city: Murrieta
country: United States
state: California
city: Nevada City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Rocklin
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Fransisco
country: United States
state: California
city: West Hollywood
country: United States
state: California
city: Whittier
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Northglenn
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Wheatridge
country: United States
state: Colorado
city: Manchester
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: North Haven
country: United States
state: Connecticut
city: Norwich
country: United States
state: Connecticut
city: Georgetown
country: United States
state: Delaware
city: Milton
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Apopka
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Cape Coral
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Deltona
country: United States
state: Florida
city: Dunnellon
country: United States
state: Florida
city: Estero
country: United States
state: Florida
city: Eustis
country: United States
state: Florida
city: Loxahatchee
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Margate
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Mount Dora
country: United States
state: Florida
city: N. Miami Beach
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Oakland Park
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Richey
country: United States
state: Florida
city: Royal Palm Beach
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Cave Spring
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Covington
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Statesboro
country: United States
state: Georgia
city: Sugar Hill
country: United States
state: Georgia
city: Rexburg
country: United States
state: Idaho
city: Clinton
country: United States
state: Illinois
city: Crestwood
country: United States
state: Illinois
city: Creve Coeur
country: United States
state: Illinois
city: Danville
country: United States
state: Illinois
city: Dekalb
country: United States
state: Illinois
city: Elmwood Park
country: United States
state: Illinois
city: Flossmoor
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Lockport
country: United States
state: Illinois
city: Maryville
country: United States
state: Illinois
city: Morton
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Pekin
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: St Charles
country: United States
state: Illinois
city: Washington
country: United States
state: Illinois
city: Washington
country: United States
state: Illinois
city: Zion
country: United States
state: Illinois
city: Anderson
country: United States
state: Indiana
city: Anderson
country: United States
state: Indiana
city: Anderson
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Franklin
country: United States
state: Indiana
city: Highland
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Laporte
country: United States
state: Indiana
city: Lawrenceburg
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Rushville
country: United States
state: Indiana
city: Seymour
country: United States
state: Indiana
city: Whiteland
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Le Claire
country: United States
state: Iowa
city: Newton
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Kansas City
country: United States
state: Kansas
city: Kansas City
country: United States
state: Kansas
city: Lansing
country: United States
state: Kansas
city: Shawnee
country: United States
state: Kansas
city: Florence
country: United States
state: Kentucky
city: London
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Monticello
country: United States
state: Kentucky
city: Russell Springs
country: United States
state: Kentucky
city: Somerset
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Chester
country: United States
state: Maryland
city: Havre De Grace
country: United States
state: Maryland
city: Ocean City
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Bloomfield Hills
country: United States
state: Michigan
city: Clarkston
country: United States
state: Michigan
city: Clinton
country: United States
state: Michigan
city: Dearborn Heights
country: United States
state: Michigan
city: Dearborn
country: United States
state: Michigan
city: Farmington Hills
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Leslie
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Mason
country: United States
state: Michigan
city: Muskegon
country: United States
state: Michigan
city: Muskegon
country: United States
state: Michigan
city: Northville
country: United States
state: Michigan
city: Okemos
country: United States
state: Michigan
city: Okemos
country: United States
state: Michigan
city: Owosso
country: United States
state: Michigan
city: Pigeon
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Southgate
country: United States
state: Michigan
city: Sterling Heights
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Waterford
country: United States
state: Michigan
city: Cold Spring
country: United States
state: Minnesota
city: Ballwin
country: United States
state: Missouri
city: Cape Girardeau
country: United States
state: Missouri
city: Chesterfield
country: United States
state: Missouri
city: Clinton
country: United States
state: Missouri
city: Florissant
country: United States
state: Missouri
city: Hazelwood
country: United States
state: Missouri
city: Jefferson City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: Mt Vernon
country: United States
state: Missouri
city: Platte City
country: United States
state: Missouri
city: Raymore
country: United States
state: Missouri
city: St Joseph
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Warrenton
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Weston
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Atco
country: United States
state: New Jersey
city: Blackwood
country: United States
state: New Jersey
city: Bloomfield
country: United States
state: New Jersey
city: Brigantine
country: United States
state: New Jersey
city: East Orange
country: United States
state: New Jersey
city: Green Brook
country: United States
state: New Jersey
city: Irvington
country: United States
state: New Jersey
city: Irvington
country: United States
state: New Jersey
city: Iselin
country: United States
state: New Jersey
city: Jersey City
country: United States
state: New Jersey
city: Jersey City
country: United States
state: New Jersey
city: Kenilworth
country: United States
state: New Jersey
city: Lakewood
country: United States
state: New Jersey
city: Mays Landing
country: United States
state: New Jersey
city: Millburn
country: United States
state: New Jersey
city: Millburn
country: United States
state: New Jersey
city: Nutley
country: United States
state: New Jersey
city: Scotch Plains
country: United States
state: New Jersey
city: South Bound Brook
country: United States
state: New Jersey
city: Totowa
country: United States
state: New Jersey
city: Union
country: United States
state: New Jersey
city: Wenonah
country: United States
state: New Jersey
city: Westville
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Glendale
country: United States
state: New York
city: Kenmore
country: United States
state: New York
city: Mayville
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Port Jefferson Station
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Suffern
country: United States
state: New York
city: Asheboro
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Akron
country: United States
state: Ohio
city: Ashtabula
country: United States
state: Ohio
city: Bowling Green
country: United States
state: Ohio
city: Canal Winchester
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cuyahoga Falls
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Defiance
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Fremont
country: United States
state: Ohio
city: Gahanna
country: United States
state: Ohio
city: Genoa
country: United States
state: Ohio
city: Hamilton
country: United States
state: Ohio
city: Hamilton
country: United States
state: Ohio
city: Kent
country: United States
state: Ohio
city: Kingston
country: United States
state: Ohio
city: Lancaster
country: United States
state: Ohio
city: Maumee
country: United States
state: Ohio
city: New Lexington
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Pickerington
country: United States
state: Ohio
city: Springboro
country: United States
state: Ohio
city: Stow
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Stillwater
country: United States
state: Oklahoma
city: Estacada
country: United States
state: Oregon
city: Eugene
country: United States
state: Oregon
city: Lake Oswego
country: United States
state: Oregon
city: Milwaukie
country: United States
state: Oregon
city: Oregon City
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Tualatin
country: United States
state: Oregon
city: Aliquippa
country: United States
state: Pennsylvania
city: Archbald
country: United States
state: Pennsylvania
city: Aston
country: United States
state: Pennsylvania
city: Avoca
country: United States
state: Pennsylvania
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Carbondale
country: United States
state: Pennsylvania
city: Chicora
country: United States
state: Pennsylvania
city: Clarks Summit
country: United States
state: Pennsylvania
city: Collegeville
country: United States
state: Pennsylvania
city: Conneaut Lake
country: United States
state: Pennsylvania
city: Cowansville
country: United States
state: Pennsylvania
city: Downingtown
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Drexel Hill
country: United States
state: Pennsylvania
city: Drums
country: United States
state: Pennsylvania
city: Dublin
country: United States
state: Pennsylvania
city: Elizabeth
country: United States
state: Pennsylvania
city: Elkins Park
country: United States
state: Pennsylvania
city: Ford City
country: United States
state: Pennsylvania
city: Greensburg
country: United States
state: Pennsylvania
city: Honesdale
country: United States
state: Pennsylvania
city: King Of Prussia
country: United States
state: Pennsylvania
city: Levittown
country: United States
state: Pennsylvania
city: McKeesport
country: United States
state: Pennsylvania
city: Montrose
country: United States
state: Pennsylvania
city: Moon Township
country: United States
state: Pennsylvania
city: Morrisville
country: United States
state: Pennsylvania
city: Mt. Pleasant
country: United States
state: Pennsylvania
city: New Castle
country: United States
state: Pennsylvania
city: New Wilmington
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Phoenixville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Royersford
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Shippensburg
country: United States
state: Pennsylvania
city: Southampton
country: United States
state: Pennsylvania
city: Springfield
country: United States
state: Pennsylvania
city: Stoneboro
country: United States
state: Pennsylvania
city: Union City
country: United States
state: Pennsylvania
city: Warminster
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Yardley
country: United States
state: Pennsylvania
city: Camden
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Marion
country: United States
state: South Carolina
city: Marion
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Ashland City
country: United States
state: Tennessee
city: Collierville
country: United States
state: Tennessee
city: Dyersburg
country: United States
state: Tennessee
city: Hendersonville
country: United States
state: Tennessee
city: Hermitage
country: United States
state: Tennessee
city: Lebanon
country: United States
state: Tennessee
city: McKenzie
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Newport
country: United States
state: Tennessee
city: Springfield
country: United States
state: Tennessee
city: Sweetwater
country: United States
state: Tennessee
city: Woodbury
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Ft Worth
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Rusk
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Valley City
country: United States
state: Utah
city: Annandale
country: United States
state: Virginia
city: Ashburn
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Reston
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Marysville
country: United States
state: Washington
city: Olympia
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Carolina
country: Puerto Rico
city: Cidra
country: Puerto Rico
city: Hato Rey
country: Puerto Rico
city: Juncos
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
name: Sherry Siegel, MD
role: STUDY_DIRECTOR
References:
citation: The American Pain Foundation. Pain Facts & Figures. January 2007. Available from http://www.painfoundation.org/print.asp?file=Newsroom/PainFacts.htm.
citation: Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.
citation: Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1.
citation: Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002 Apr;23(4):278-91. doi: 10.1016/s0885-3924(02)00383-4.
citation: Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006 May-Jun;2(3):155-66. doi: 10.5055/jom.2006.0025.
citation: Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. J Opioid Manag. 2006 Nov-Dec;2(6):325-8, 331-3. doi: 10.5055/jom.2006.0048.
citation: Rosenthal M, Moore P, Groves E, Iwan T, Schlosser LG, Dziewanowska Z, Negro-Vilar A. Sleep improves when patients with chronic OA pain are managed with morning dosing of once a day extended-release morphine sulfate (AVINZA): findings from a pilot study. J Opioid Manag. 2007 May-Jun;3(3):145-54. doi: 10.5055/jom.2007.0052.
citation: Katz NP, Adams EH, Chilcoat H, Colucci RD, Comer SD, Goliber P, Grudzinskas C, Jasinski D, Lande SD, Passik SD, Schnoll SH, Sellers E, Travers D, Weiss R. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007 Oct;23(8):648-60. doi: 10.1097/AJP.0b013e318125c5e8.
citation: Ives TJ, Chelminski PR, Hammett-Stabler CA, Malone RM, Perhac JS, Potisek NM, Shilliday BB, DeWalt DA, Pignone MP. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006 Apr 4;6:46. doi: 10.1186/1472-6963-6-46.
citation: Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005 Mar-Apr;6(2):107-12. doi: 10.1111/j.1526-4637.2005.05031.x.
citation: 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.