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OpenTrials
Completed

NCT Number: NCT03659734

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

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.

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Key information

Conditions

Opioid Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing and Guided Opioid Tapering Support

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)

    Time frame: Through study completion, 1 year after surgery

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 6, 2018
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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