RECRUITING

Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

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Conditions

Opioid Use DisorderBack PainStress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see how stress influences the effects of opioid pain medications often used to help relieve back pain. The study will help to learn more about how high stress levels could increase risk for pain medication misuse.

Official Title

Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

Quick Facts

Study Start:2022-03-02
Study Completion:2026-03-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05142267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Intact cognitive status and ability to provide informed consent
  2. * Ability to read and write in English sufficiently to understand and complete study questionnaires (which are only validated in English)
  3. * Age 18 or older And
  4. * Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity
  1. * History of renal or hepatic dysfunction
  2. * Reports of current or past alcohol or substance abuse or treatment for such condition
  3. * A reported history of PTSD, psychotic, or bipolar disorders
  4. * Chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus)
  5. * Reports of recent benzodiazepine use (confirmed via rapid urine screening prior to each lab session)
  6. * Any medical conditions (e.g., significant cardiovascular disease) that the study physician feels would contraindicate participation in the lab stressors
  7. * Reported daily opiate use within the past 6 months, or use of any opioid analgesic medications within 3 days of study participation (confirmed through rapid urine screening prior to each lab session)
  8. * Pregnancy (females only, to avoid fetal drug exposure - pregnancy tests conducted prior to each lab session to confirm eligibility)
  9. * Prior allergic reaction/intolerance to oxycodone or its analogs

Contacts and Locations

Study Contact

Stephen Bruehl, PhD
CONTACT
615-936-1821
stephen.bruehl@vumc.org
Gail Mayo
CONTACT
615-936-1705
gail.mayo@vumc.org

Principal Investigator

Stephen Bruehl, PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Stephen Bruehl, PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02
Study Completion Date2026-03-24

Study Record Updates

Study Start Date2022-03-02
Study Completion Date2026-03-24

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Back Pain
  • Stress