Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

NCT04888962 | Completed DMC

• 1 other identifier: STUDY20060069
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational case-control study comparing quantitative sensory testing data preformed during the third trimester of pregnancy and within 24 hours postpartum in women on medication-assisted treatment for opioid use disorder (OUD) to a gestational age-controlled cohort of women who do not have OUD. The primary goal is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.

Conditions

Opioid-use Disorder; Pregnancy Related

Outcome Measures

Primary Outcomes (4)

• QST Pain threshold

  Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain

  Completed at a time point antepartum/ before delivery

• QST Pain Tolerance

  Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.

  Completed at a time point antepartum/ before delivery

• QST Pain Threshold

  Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain

  Completed within 24 hours postpartum/ after delivery

• QST Pain Tolerance

  Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.

  Completed within 24 hours postpartum/ after delivery

Study Arms (2)

Prospective cohort group

This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until 24 hours postpartum.

Other: OUD

Control group

This cohort will include pregnant patients without a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until 24 hours postpartum.

Interventions

OUD OTHER

History of opioid use disorder.

Prospective cohort group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.

You may qualify if:

• Subjects that will be included in the prospective cohort group:
• individuals at least 18 years of age
• at least 28 weeks gestation (third trimester)
• on medication-assisted treatment for opioid use disorder, including methadone or suboxone.
• Patients who will be included in the control group:
• individuals at least 18 years of age
• at least 28 weeks gestation (third trimester)
• have not been on been on opioids in the past 12 months.

You may not qualify if:

• Those who are unable to participate in informed consent discussions,
• Unable to give informed consent for any reason,
• Not fluent in English (surveys are validated in English language)
• Unable to participate fully in all study procedures for any reason including sensory deficits, scar tissue, or infection at any QST sites.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Grace Lim, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: June 14, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)