RECRUITING

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

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

Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.

Official Title

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Quick Facts

Study Start:2022-02-01
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05027919

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 to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years - 65 year old
  2. * Opioid-positive urine sample
  3. * Current opioid use disorder with evidence of physical dependence
  4. * Interest in undergoing opioid taper
  1. * Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention
  2. * Being pregnant or breastfeeding
  3. * Enrolled in methadone or buprenorphine maintenance treatment
  4. * Clinically significant hypotension (\<90/60mmHg) or bradycardia (\<45bpm)
  5. * History of myocardial infarction
  6. * Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
  7. * Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation

Contacts and Locations

Study Contact

Kelly E Dunn, Ph.D, M.B.A.
CONTACT
410-550-2254
kdunn9@jhmi.edu
Breanna Labos
CONTACT
blabos1@jhmi.edu

Principal Investigator

Kelly E Dunn, Ph.D, M.B.A.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University Bayview Medical Campus
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Kelly E Dunn, Ph.D, M.B.A., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Date2022-02-01
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Withdrawal
  • Opioid Use Disorder
  • Opioid Craving