Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation

NCT ID: NCT03659734

Last Updated: 2025-01-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2024-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Motivational Interviewing and Guided Opioid Tapering Support

Group Type EXPERIMENTAL

Motivational Interviewing and Guided Opioid Tapering Support

Intervention Type BEHAVIORAL

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 Care

Group Type EXPERIMENTAL

Enhanced Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

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Motivational Interviewing and Guided Opioid Tapering Support

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Any conditions causing inability to complete assessments
* Known pregnancy
* Elevated suicidality
* Enrollment in conflicting perioperative trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Hah, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01DA045027-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-43163

Identifier Type: -

Identifier Source: org_study_id

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