NCT01625065

Brief Summary

In this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. The aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. Expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

June 19, 2012

Last Update Submit

June 20, 2012

Conditions

Pain

Keywords

medication complianceadherencetoxicological analyzesGC-MSHPLCpain patientsopioid misusepatients with current pain

Study Arms (2)

pain patients

patients from a specific pain management department, patients with long duration of pain, mostly insufficiently treated pain

pre-surgical patients

patients from a surgical outpatient department with current pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pain management and surgical outpatient department of a University hospital

You may qualify if:

  • provided informed consent
  • current pain

You may not qualify if:

  • no taking of blood sample possible
  • no consent with toxicological analyzes
  • insufficient comprehension of the German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Bergmannsheil

Bochum, Germany

Location

Related Publications (1)

  • Kipping K, Maier C, Bussemas HH, Schwarzer A. Medication compliance in patients with chronic pain. Pain Physician. 2014 Jan-Feb;17(1):81-94.

    PMID: 24452648DERIVED

Biospecimen

serum, urine

MeSH Terms

Conditions

PainMedication AdherenceOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

DE(1)