NCT02871232

Brief Summary

To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,500

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

First QC Date

August 15, 2016

Last Update Submit

August 24, 2016

Conditions

Opioid-related DisordersOpioid AddictionNarcotic AbuseDrug Abuse

Outcome Measures

Primary Outcomes (1)

  • Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups

    Review over period from January 2010 to December 2016

Secondary Outcomes (1)

  • Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group

    Review over period from January 2010 to December 2016

Study Arms (2)

Intentional exposures among adolescents and adults

Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

Unintentional exposures among infants and children

Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

Interventions

Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversionOTHER
Intentional exposures among adolescents and adultsUnintentional exposures among infants and children

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school

You may qualify if:

  • Any patient with data in the RADARS system

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Primary Completion

December 1, 2016

Last Updated

August 25, 2016

Record last verified: 2016-08