Opioid CessationPROMPTNCT02070003
Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
A study testing Motivational Interviewing and Physician Guided Opioid Weaning in people with Opioid Cessation, run by Stanford University at 1 site in United States.
Trial summary
The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. 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 Physician Guided Opioid Weaning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2014to 15 Aug 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Undergoing a scheduled surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments.
Who cannot join
- Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
- Known Pregnancy
- Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
- Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.
- Conditions
- Opioid Cessation
- Being tested
- Motivational Interviewing and Physician Guided Opioid Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Physician Guided Opioid WeaningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing and Physician Guided Opioid Weaning | Experimental | Patients will go through motivational interviewing with the study physician via phone once a week for 7 weeks, and once a month up to a year as applicable, until patient completes the protocol. Receives: Behavioral: Motivational Interviewing and Physician Guided Opioid Weaning |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.
Measured: Duration of the study - up to 2 years per participant
Secondary outcomes (1)
Efficacy - time to opioid cessation
Time to opioid cessation between the two groups will be analyzed using survival analysis
Measured: Duration of the trial - Up to 2 years per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study start26 Nov 2014
- Primary completion26 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hah, Stanford University
- Investigators
- Jennifer Hah, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070003
- Sponsor's protocol ID
- 26234
- Acronym
- PROMPT
- Status last verified
- Jul 2020
- First submitted
- 10 Feb 2014
- Last updated
- 10 Jul 2020
- Results posted
- No
Publications
Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.
PubMed 33294812
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
- ClinicalTrials.gov ID
- NCT02070003
- Acronym / sponsor ID
- PROMPT / 26234
- Conditions
- Opioid Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Nov 2014 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 24 Feb 2014 (estimated)
- 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.
The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing and Physician Guided Opioid Weaning | Experimental | Behavioral: Motivational Interviewing and Physician Guided Opioid WeaningPatients will go through motivational interviewing with the study physician via phone once a week for 7 weeks, and once a month up to a year as applicable, until patient completes the protocol. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Undergoing a scheduled surgery
- English speaking
- Ability and willingness to complete questionnaires and assessments.
Key exclusion criteria (4 listed)
- Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
- Known Pregnancy
- Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
- Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target
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 Physician Guided Opioid Weaning | Behavioural | Motivational Interviewing and Physician Guided Opioid Weaning |
Primary outcome
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
Time frame: Duration of the study - up to 2 years per participant
Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.
1 secondary outcome
Efficacy - time to opioid cessation
Time frame: Duration of the trial - Up to 2 years per participant
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 10 Jul 2020.
- Derived from this study: PubMed 33294812Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.
Related trials for Opioid Cessation
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
RecruitingEarly Phase 1
Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruiting
Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use Disorder
Opioid Use Disorder, Tobacco Use Disorder
RecruitingPhase 3
Suzetrigine in Total Hip Arthroplasty
Total Hip Arthroplasty (THA), Total Hip Arthroplasty \(THA\)
Recruiting
Opioids, Low Nicotine Cigarettes, and Chronic Pain
Chronic Pain, Tobacco Use
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, MS 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 Physician Guided Opioid Weaning 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 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 10 Jul 2020. 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?
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized (time frame: Duration of the study - up to 2 years per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070003, which also lists 1 linked publication.
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 10 Jul 2020.