NCT02678507

Brief Summary

The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

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

April 7, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

February 5, 2016

Last Update Submit

April 14, 2020

Conditions

Opioid-Related DisordersOpiate AddictionNarcotic AbuseDrug Abuse

Outcome Measures

Primary Outcomes (1)

  • Identification Validity of the POMAQ in misuse and abuse of prescription opioid behaviors

    Single Survey, with re-test in 20% of population 7-10 days after initial completion

Study Arms (1)

Patients with chronic pain on opioids

Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Interventions

Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)OTHER
Patients with chronic pain on opioids

Eligibility Criteria

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

Patients within the Department of Defense (DoD)/TriCare health system with chronic (\>3 months) pain treated with opioids.

You may qualify if:

  • Age ≥ 18 years;
  • Diagnosed chronic pain (≥ 3 months) condition which requires long-term treatment with opioids;
  • Willingness to provide written informed consent; and
  • Able to participate in and complete an Internet-based survey and a telephone interview in English.

You may not qualify if:

  • Cognitive or other impairment based on the Principal Investigator's judgment that would interfere with the ability of a participant to complete the validation study
  • Terminal illness with life expectancy \<6 months.

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 Officials

  • Alexandra Barsdorf, Ph.D.

    Pfizer

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

April 7, 2015

Primary Completion

June 21, 2017

Study Completion

June 21, 2017

Last Updated

April 15, 2020

Record last verified: 2020-04