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Completed

NCT Number: NCT02070003

Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)

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.

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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

  • Age 18+
  • Undergoing a scheduled surgery
  • English speaking
  • Ability and willingness to complete questionnaires and assessments.

Exclusion criteria

  • 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

Treatment and study plan

Motivational Interviewing and Physician Guided Opioid Weaning

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Efficacy - time to opioid cessation

    Time frame: Duration of the trial - Up to 2 years per participant

    Time to opioid cessation between the two groups will be analyzed using survival analysis

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: PROMPT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2014
Registry last updated
Jul 10, 2020

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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