Opioid CessationNCT03659734
Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation
A study testing Motivational Interviewing and Guided Opioid Tapering Support in people with Opioid Cessation, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Cessation
- What is being tested?
- Motivational Interviewing and Guided Opioid Tapering Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 3 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments
- Scheduled for total hip, knee, or shoulder replacement
- Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation.
- Not under the care of a current pain management provider
Who cannot join
- Any conditions causing inability to complete assessments
- Known pregnancy
- Elevated suicidality
- Enrollment in conflicting perioperative trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: Randomized Controlled Trial to Evaluate the Relative Efficacy of Motivational Interviewing and Guided Opioid Tapering Support vs. Enhanced Usual Care to Promote Opioid Cessation After Orthopedic Surgery
The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.
- Conditions
- Opioid Cessation
- Being tested
- Motivational Interviewing and Guided Opioid Tapering Support, Enhanced Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Guided Opioid Tapering SupportBehavioural
Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
Enhanced Usual CareBehavioural
Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing and Guided Opioid Tapering Support | Experimental | Not described Receives: Behavioral: Motivational Interviewing and Guided Opioid Tapering Support |
| Enhanced Usual Care | Experimental | Not described Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Opioid Cessation
Time to opioid cessation between the two groups will be analyzed using survival analysis
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)
Assessed by total score on the Current Opioid Misuse Measure (COMM). The Current Opioid Misuse Measure is a self-report measure of risk for aberrant medication related behavior among persons who are prescribed opioids for pain. The COMM contains 17 items rated from 0="never" to 4="very often" . The 17 items are summed to create a total score with a minimum of 0 to a maximum of 68. Higher scores represent a higher risk of potential opioid medication misuse (worse outcome). Patients exhibiting opioid misuse (binary outcome) were defined as those reporting a postoperative COMM score greater than or equal to 9.
Measured: Through study completion, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start12 Jul 2019
- Primary completion23 Aug 2023
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid CessationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Hah, Stanford University
- Investigators
- Jennifer Hah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659734
- Sponsor's protocol ID
- IRB-43163
- Other IDs
- 1R01DA045027-01A1
- Status last verified
- Jan 2025
- First submitted
- 10 Apr 2018
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Relative Efficacy of Motivational Interviewing and Guided Opioid Tapering Support vs. Enhanced Usual Care to Promote Opioid Cessation After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03659734
- Acronym / sponsor ID
- IRB-43163
- Conditions
- Opioid Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing and Guided Opioid Tapering Support | Experimental | Behavioral: Motivational Interviewing and Guided Opioid Tapering Support |
| Enhanced Usual Care | Experimental | Behavioral: Enhanced Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Planning to undergo surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments
- Scheduled for total hip, knee, or shoulder replacement
- Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation.
Key exclusion criteria (4 listed)
- Any conditions causing inability to complete assessments
- Known pregnancy
- Elevated suicidality
- Enrollment in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing and Guided Opioid Tapering SupportFollowing surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol. | Behavioural | Motivational Interviewing and Guided Opioid Tapering Support |
| Enhanced Usual CareFollowing surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol. | Behavioural | Enhanced Usual Care |
Primary outcome
Time to Opioid Cessation
Time frame: Through study completion, an average of 1 year
Time to opioid cessation between the two groups will be analyzed using survival analysis
1 secondary outcome
Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)
Time frame: Through study completion, 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Hah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Guided Opioid Tapering Support in people with Opioid Cessation, run by Stanford University 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 6 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 17 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Through study completion, an average of 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 17 Jan 2025.