ARRA IMPACT REPORT:
Comparative Effectiveness Research for the Prevention and Treatment of Addiction and Related Disorders


Public Health Burden
Substance abuse and addiction can devastate the lives and health of individuals, as well as their families and communities. The societal costs incurred from crime, lost productivity, and increased health care costs related to substance abuse amount to over $600 billion dollars annually. Interventions to counter these dangerous and costly trends benefit from studies that compare emergent approaches demonstrating efficacy, and those already in use. Comparative effectiveness research helps to optimize strategies for disseminating and implementing effective treatments across diverse settings and patient populations.

Development of Addiction Medications
Probuphine – An Implantable Drug Therapy to Treat Opiod Addiction: Patient noncompliance and the potential for abuse and diversion are a concern with some existing drug treatments for substance use disorders, such as naltrexone and buprenorphine in the treatment of opioid addiction. NIDA works closely with pharmaceutical companies to develop new delivery systems that will boost the effectiveness and safety of existing medications. Probuphine, a long-acting version of buprenorphine, has shown promise in clinical trials for the long-term treatment of opioid dependence. Recently, Titan Pharmaceuticals released the highlights of a completed Phase III clinical trial demonstrating the safety and efficacy of Probuphine in reducing opioid abuse, with comparable results to sublingual buprenorphine. Probuphine, an implantable form of buprenorphine inserted under the skin, allows continuous delivery of the medication for six months after a single treatment. Like Vivitrol, a long-acting version of naltrexone, it aims to prevent abuse and diversion and increase treatment adherence by eliminating the need for daily dosing. With ARRA support, preparation of a New Drug Application (NDA) is in process and is expected to be ready for submission in September 2012, according to the company’s website.1

Effective Chronic Pain Management
Clinically-based Chronic Pain Data Registry: Chronic pain is a major public health problem that is growing worse as the gaps in our knowledge base continue and the population at risk grows. Identifying pain management interventions that are most effective for specific patient-types with chronic pain would provide a cost-effective solution to address this devastating problem. With ARRA funding, researchers at Weill Medical College are developing the first clinically-based retrospective and prospective chronic pain data registry for patients of four New York City academic hospital-based Pain Clinics that employ interdisciplinary pain management treatments.2 The retrospective registry includes existing electronic medical record (EMR) data on patient demographic characteristics, pre-morbid status, injury and/or disease-related conditions (complications and comorbidities), therapeutic interventions, and outcomes including measures of pain intensity, functional improvements, subjective well-being, as well as treatment related adverse effects (prescription opioid abuse). The accrual of clinic patients for the prospective study began after the software program for the patient survey was pilot tested and finalized. Since then they have accumulated more than 1000 chronic pain patients from the four pain clinics. This state-of-the-art data capture system for chronic pain registries will allow providers to efficiently collect data for analyses to determine which patients will derive maximum benefit from the currently available interventions used for the management of chronic pain.

Contributing NIH Institutes & Centers

  • National Institute on Drug Abuse (NIDA)

  1. http://www.titanpharm.com/press/2012/120420-press-rel-titan-asam-presentation.htm
    1RC2DA028910-01 - BEEBE, KATHERINE L - TITAN PHARMACEUTICALS, INC. - SOUTH SAN FRANCISCO - CA
  2. 1RC2DA028928-01, http://www.ncbi.nlm.nih.gov/pubmed/21834914 - INTURRISI, CHARLES E - WEILL MEDICAL COLLEGE OF CORNELL UNIV - NEW YORK - NY