RECRUITING

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

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 proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

Official Title

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

Quick Facts

Study Start:2023-05-16
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05336188

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. * Sex: male or female
  2. * Age: 18 years and older
  3. * (MRI sub-study): Age: 18-50 years old
  4. * In Phase I treatment of MAT for opioid-use disorder. (Phase I indicates that patient is receiving no more than one week of take-home medications at each weekly clinic visit.)
  5. * Must be willing to use a smartphone if randomized to the smartphone intervention arm
  6. * (MRI sub-study): Native English-speaking
  1. * (MRI) Medical history: A history of neurological, cardiovascular, or infectious disease would exclude study participation. A loss of consciousness of 20 or more min or other evidence of brain trauma also would be exclusionary.
  2. * (MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.
  3. * (MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity

Contacts and Locations

Study Contact

Andrew James, Ph.D.
CONTACT
501-526-8345
GAJames@uams.edu

Principal Investigator

Andrew James, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

Brain Imaging Research Center
Little Rock, Arkansas, 72227
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Andrew James, Ph.D., PRINCIPAL_INVESTIGATOR, University of Arkansas

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 Date2023-05-16
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2023-05-16
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid-Related Disorders
  • Mobile Applications
  • Opiate Substitution Treatment
  • Magnetic Resonance Imaging
  • Craving
  • Attentional Bias
  • Ecological Momentary Assessment