Opioid UseNCT05412342
Characterizing the Association Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery
An observational study of Opioid Use, run by Stanford University at 2 sites in United States.
Trial summary
This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- How many people
- 718 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2019to 3 Mar 2024
- 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
- All sexes
- Adult, Older adult
Study population: Patients undergoing elective surgery at Stanford Hospital.
Who may be able to join
- Age 18+
- Planning to undergo surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments
Who cannot join
- Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- Known Pregnancy
- Elevated Suicidality
- Enrollment in a conflicting perioperative trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University School of Medicine
Palo Alto, California, 94304
Stanford Health Care
Stanford, California, 94304
About this study
Official title: Observational Study to Characterize the Relationship Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery
This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.
- Conditions
- Opioid Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing elective operations | We will follow a prospective cohort of 558 patients, undergoing any elective surgery at Stanford Hospital. Subjects will undergo baseline and longitudinal testing via a (including NIH Patient-Reported Outcomes Measurement Information System- PROMIS measures of emotional distress). After surgery, participants will report weekly changes in opioid use, pain, and adverse events; and monthly changes in opioid misuse for 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Opioid Cessation
Measured: Assessed after surgery up to 1 year
Secondary outcomes (1)
Opioid Misuse
Participant score on the Current Opioid Misuse Measure will be used to assess opioid misuse
Measured: Assessed after surgery up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start10 May 2019
- Primary completion3 Mar 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412342
- Sponsor's protocol ID
- 43163
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Characterize the Relationship Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery
- ClinicalTrials.gov ID
- NCT05412342
- Acronym / sponsor ID
- 43163
- Conditions
- Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 9 Jun 2022 (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 observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective operations | – | –We will follow a prospective cohort of 558 patients, undergoing any elective surgery at Stanford Hospital. Subjects will undergo baseline and longitudinal testing via a (including NIH Patient-Reported Outcomes Measurement Information System- PROMIS measures of emotional distress). After surgery, participants will report weekly changes in opioid use, pain, and adverse events; and monthly changes in opioid misuse for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery at Stanford Hospital.
Key inclusion criteria (4 listed)
- Age 18+
- Planning to undergo surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments
Key exclusion criteria (4 listed)
- Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- Known Pregnancy
- Elevated Suicidality
- Enrollment in a conflicting perioperative trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Opioid Cessation
Time frame: Assessed after surgery up to 1 year
1 secondary outcome
Opioid Misuse
Time frame: Assessed after surgery up to 1 year
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 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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, run by Stanford University at 2 sites 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 4 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time to Opioid Cessation (time frame: Assessed after surgery up to 1 year). 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 18 Dec 2024.