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Clinical Trials/NCT02070003
NCT02070003
Completed
Not Applicable

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

Stanford University1 site in 1 country104 target enrollmentNovember 26, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Cessation
Sponsor
Stanford University
Enrollment
104
Locations
1
Primary Endpoint
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
Status
Completed
Last Updated
5 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 26, 2014
End Date
August 15, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Hah

Assistant Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • Efficacy - time to opioid cessation(Duration of the trial - Up to 2 years per participant)

Study Sites (1)

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