Opioid-use DisorderQ-PRONTONCT04888962
Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD
An observational study of Opioid-use Disorder and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Pregnancy Related
- What is being tested?
- OUD
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
The objective of this study 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.
The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Being tested
- OUD
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OUDOther
History of opioid use disorder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Completed within 24 hours postpartum/ after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start14 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888962
- Sponsor's protocol ID
- STUDY20060069
- Acronym
- Q-PRONTO
- Status last verified
- Oct 2021
- First submitted
- 11 May 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD
- ClinicalTrials.gov ID
- NCT04888962
- Acronym / sponsor ID
- Q-PRONTO / STUDY20060069
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study 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.
The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort group | – | Other: OUDThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.
Key inclusion criteria (8 listed)
- 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.
- individuals at least 18 years of age
- at least 28 weeks gestation (third trimester)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OUDHistory of opioid use disorder. | Other | Prospective cohort group |
Primary outcome
QST Pain threshold
Time frame: Completed at a time point antepartum/ before delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
QST Pain Tolerance
Time frame: Completed at a time point antepartum/ before delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.
QST Pain Threshold
Time frame: Completed within 24 hours postpartum/ after delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
QST Pain Tolerance
Time frame: Completed within 24 hours postpartum/ after delivery
Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Lim, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QST Pain threshold (time frame: Completed at a time point antepartum/ before delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.