RECRUITING

Neuromodulation and Cognitive Training 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 relapsing nature of opioid use disorder is a major obstacle to successful treatment. About 90% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity.

Official Title

Neuromodulation and Cognitive Training in Opioid Use Disorder

Quick Facts

Study Start:2019-08-01
Study Completion:2025-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03773523

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
  2. * This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
  3. * Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.
  1. * Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
  2. * A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
  3. * Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
  4. * DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
  5. * Presence of a condition that would render study measures difficult or impossible to administer or interpret
  6. * Age outside the range of 18 to 60
  7. * Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
  8. * Clinical evidence for Wernicke-Korsakoff syndrome
  9. * Nicotine use will be recorded.

Contacts and Locations

Study Contact

Jazmin Y Camchong, PhD
CONTACT
(612) 624-0134
camch002@umn.edu
Lamisa N Chowdhury, BS
CONTACT
(612) 626-6808
chow0082@umn.edu

Principal Investigator

Jazmin Y Camchong, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Kelvin O Lim, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Jazmin Y Camchong, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Kelvin O Lim, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Date2019-08-01
Study Completion Date2025-05-15

Study Record Updates

Study Start Date2019-08-01
Study Completion Date2025-05-15

Terms related to this study

Keywords Provided by Researchers

  • tDCS
  • Transcranial Direct Current Stimulation
  • MRI
  • Opioid dependence
  • Opioids
  • Buprenorphine
  • Suboxone
  • Lodging Plus
  • Fairview Lodging Plus

Additional Relevant MeSH Terms

  • Opioid-use Disorder
  • Opioid Dependence
  • Opioid Abuse