Opioid-Related Disorders Clinical Trial
Official title:
Retrospective Cohort Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Diversion, Abuse and/or Addiction by Medical Record Review
Verified date | April 2020 |
Source | Member Companies of the Opioid PMR Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.
Status | Completed |
Enrollment | 590 |
Est. completion date | June 21, 2017 |
Est. primary completion date | June 21, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012 2. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. 3. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period. 4. Patients with continuous enrollment during the follow-up period of 18 months Exclusion Criteria: 1. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories 2. Patients for whom no medical records can be accessed 3. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Member Companies of the Opioid PMR Consortium | HealthCore, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentages of patients in each category having at least one and up to 34 (all) of the prespecified list of behaviors suggestive of misuse, diversion, abuse and/or addiction in their medical records | Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up | ||
Primary | The correlation among the behaviors suggestive of misuse, diversion, abuse and/or addiction | Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up |
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 | |
Terminated |
NCT00000243 -
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
|
N/A | |
Completed |
NCT00067184 -
Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
|
||
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 |