Clinical Trials Logo
  1. Home
  2. Opioid-Related Disorders
  3. NCT02751762

A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain

Opioid-Related Disorders Clinical Trial

Official title:
A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain

Clinical Trial Summary

The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.

Clinical Trial Description

The Food and Drug Administration (FDA) has asked the companies that are New Drug Application (NDA) holders of extended-release/long-acting (ER/LA) opioids to conduct one or more studies to provide quantitative estimates of the serious risks of prescription opioid misuse or abuse or opioid use disorder associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products. Although abuse and misuse of prescription opioids have increased over the past decade, there is debate about the magnitude of misuse, abuse, and addiction among patients who are treated with prescription opioids for chronic pain. Further, although there appears to be comorbidity of opioid use disorders with other substance use and psychiatric disorders, there is insufficient data to estimate how the risk of these outcomes varies by the presence of risk factors among patients treated with opioids long-term. This study seeks to fill that gap. The primary objective is to quantify the serious risks of prescription opioid misuse or abuse or OUD associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed opioid products. Patients will be recruited from seven Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site; and clinics participating in two Primary Care Practice-Based Research Network sites. The data sources for the proposed study will be: 1) patient reported outcomes through in-person interviews (or phone if unavailable to participate in-person), 2) web-based assessments (or phone if unable to complete via web), and 3) electronic medical record and claims data. The study design includes two components: 1) a prospective longitudinal study of patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy, and 2) a cross-sectional study of patients who have been treated with opioids (including at least one ER/LA opioid) for at least one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02751762
Study type Observational
Source Member Companies of the Opioid PMR Consortium
Contact
Status Active, not recruiting
Phase
Start date November 1, 2017
Completion date March 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03950492 - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder N/A
Completed NCT00000335 - Activity Monitoring Assessment of Opiate Withdrawal - 4 Phase 2
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02978417 - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings Phase 4
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT00710385 - Abuse Liability of Suboxone Versus Subutex Phase 3
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Completed NCT00067184 - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Terminated NCT00000243 - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone N/A
Completed NCT00000264 - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16 N/A
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000279 - Novel Medications for Opiate Detoxification - 4 Phase 2
Completed NCT00000249 - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1 Phase 2
Recruiting NCT04933084 - Pre-operative Education Modalities to Decrease Opioid Use N/A
Recruiting NCT03610672 - Mobile Intervention for Young Opioid Users N/A