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Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

Dennis C Turk1, Alec B O'Connor, Robert H Dworkin

  • 1University of Washington, Seattle, Washington, USA University of Rochester, Rochester, New York, USA Johns Hopkins University, Baltimore, Maryland, USA Analgesic Solutions and Tufts University, Boston, Massachusetts, USA Covance, Conshohocken, Pennsylvania, USA Harvard Medical School, Boston, Massachusetts, USA Columbia University, New York, USA Denver Health Authority and Rocky Mountain Poison and Drug Center, Denver, Colorado, USA University of North Carolina, Chapel Hill, North Carolina, USA National Institute on Drug Abuse, Bethesda, Maryland, USA United States Food and Drug Administration, Silver Spring, Maryland, USA CNS Drug Consulting, McLean, Virginia, USA University of Chicago, Chicago, Illinois, USA Endo Pharmaceuticals, Chadds Ford, Pennsylvania, USA American Chronic Pain Association, Rocklin, California, USA AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA Brigham and Women's Hospital, Boston, Massachusetts, USA AcelRx Pharmaceuticals, Redwood City, California, USA University of Texas Health Science Center San Antonio, San Antonio, Texas, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey, USA Pfizer, New Brunswick, New Jersey, USA Clinical Research and Pain Clinic, Salt Lake City, Utah, USA NAMA Recovery, Cedar Park, Texas, USA.

Pain
|July 10, 2012
PubMed

Insights

Developing abuse-deterrent opioids requires comprehensive clinical studies. Research should assess abuse liability, circumvention potential, misuse in diverse patient groups, and postmarketing data for effective pain management and risk reduction.

Area of Science:

  • Pharmacology
  • Clinical Research
  • Public Health

Background:

  • Opioids are crucial for pain management but carry risks of abuse, overdose, and diversion.
  • Developing abuse-deterrent formulations (ADFs) is a key strategy to mitigate these risks.
  • Standardized methods are needed to evaluate the efficacy of ADFs.

Purpose of the Study:

  • To propose recommendations for clinical study designs to assess the abuse deterrence of opioid formulations.
  • To guide the evaluation of novel opioid products aimed at reducing misuse and abuse.
  • To establish a framework for assessing the real-world effectiveness of abuse-deterrent opioids.

Main Methods:

  • Summarized a consensus meeting focused on clinical study recommendations for opioid abuse deterrence.
  • Proposed a multi-faceted approach to evaluating abuse-deterrent properties.
  • Emphasized the need for diverse study populations and designs.

Main Results:

  • Recommended studies assessing abuse liability in various populations.
  • Advocated for evaluating the potential for abusers to circumvent deterrent features.
  • Included assessing misuse and abuse in randomized controlled trials with at-risk and low-risk pain patients.
  • Highlighted the importance of postmarketing epidemiological studies.

Conclusions:

  • A comprehensive evaluation strategy is essential for abuse-deterrent opioid formulations.
  • Multiple study types, including clinical trials and postmarketing surveillance, are necessary.
  • Assessing abuse deterrence requires understanding both intrinsic formulation properties and human behavior in diverse contexts.

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