NCT02660606

Brief Summary

The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

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

January 2, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

January 14, 2016

Last Update Submit

April 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Content validity of POMAQ

    Evidence of content validity from patients regarding the interpretation of POMAQ items, ease of completion, the comprehensiveness of instrument, and the appropriateness of the format, response scales, and recall period

    Day 1, based upon survey completed at single visit

Study Arms (4)

Group 1: Opioid abusers

Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Group 2: Abusers of other substances

Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Group 3: Non-opioid abusers

Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Group 4: Non-opioid users

Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

Interventions

Group 1: Opioid abusersGroup 2: Abusers of other substancesGroup 3: Non-opioid abusersGroup 4: Non-opioid users

Eligibility Criteria

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

Patients with chronic pain recruited from primary care or chronic pain clinics

You may qualify if:

  • Age ≥ 18 years
  • Patients who, based on the Site Investigator's clinical judgment, have chronic moderate to severe pain
  • Willing to provide written informed consent
  • Able to participate in a one-on-one interview
  • Able to read, speak, and understand English and complete all study assessments.

You may not qualify if:

  • Cognitive, psychiatric or other impairment based on the Site Investigator's clinical judgment that would interfere with participating in a one-on-one discussion
  • Terminal illness with life expectancy \< 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidera

Bethesda, Maryland, 20814, United States

Location

Related Publications (1)

  • Coyne KS, Schnoll SH, Butler SF, Barsdorf AI, Currie BM, Maziere JY, Pierson RF, Porter LN, Franks CMJ Jr, Farrar JT. Clinical scoring algorithm for the prescription opioid misuse and abuse questionnaire (POMAQ). Curr Med Res Opin. 2022 Jun;38(6):971-980. doi: 10.1080/03007995.2022.2065139. Epub 2022 May 13.

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

January 14, 2016

First Posted

January 21, 2016

Study Start

January 2, 2015

Primary Completion

January 18, 2016

Study Completion

January 18, 2016

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations