RECRUITING

tDCS and Impulsivity

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

Substance use disorder (SUD) affects more than 23 million Americans and claims more than 70,000 lives annually. With 40-60% relapse rate, SUD patients are high hospital utilizers, 65% of the incarcerated population, and are at high-risk for overdose and deaths. There is a pressing need for research in this area to advance beyond traditional pharmacological and behavioral therapies toward a greater focus on the mechanisms of risk for relapse and to improve personalization for SUD treatment. Neuromodulation has shown promise to stimulate neuronal growth without any of the side effects of medications or electroconvulsive therapy. Using transcranial direct current stimulation (tDCS) to modulate cortical activity has shown to be a viable therapy in medicine-resistant depression, to reduce opioid cravings, and impulse control. The proposed research plans to recruit 30 subjects with a history of substance use disorder (SUD). This may include a history of addiction to opioids, cocaine, and barbiturates. Addiction to alcohol and cannabinoids (marijuana) will be excluded from this study. Following recruitment and consent, the subject will be administered an EEG, Acceptance Commitment Therapy exercise followed by EEG, and a BIS-11 Survey measuring levels of impulsivity. During the next week, the patient will undergo 5 visits consisting of a pre-EEG, tDCS, and post-EEG. Half of the subjects (n=15) will receive treatment, while the other half will be in a sham group. After the completion of the 5 tDCS visits, the patient will again be administered an EEG, ACT exercise followed by EEG, and a final BIS-11 survey measuring for end impulsivity levels.

Official Title

Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder

Quick Facts

Study Start:2023-06-01
Study Completion:2023-10-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05845164

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 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18-79 years old
  2. * Gender: Any
  3. * Ethnicity: Any
  4. * Diagnosis of substance use disorder and a recent history of substance use (\<24 months last use), but not currently reporting use.
  1. * Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime)); mental retardation.
  2. * History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  3. * Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  4. * Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  5. * Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  6. * Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  7. * Female subject who is pregnant.
  8. * Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; Note that translation of the proposed ACT activity into English has not been validated and that we cannot be confident that they would be accurately translated and validated.
  9. * Minors
  10. * Older than 79 years old
  11. * last use \>24 months
  12. * history of EEG or any electrical implant (i.e. pacemaker)
  13. * history of Parkinson's, diagnosis of bipolar, schizophrenia/schizo-affective d/o, OCD, epilepsy, alzheimers
  14. * primary drug of choice alcohol or marijuana
  15. * taking antipsychotic drugs

Contacts and Locations

Study Contact

Allison J Huff, DHEd
CONTACT
520-626-2719
allison7@arizona.edu
Leena F Idris, BS
CONTACT
5202474415
idris1@arizona.edu

Principal Investigator

Allison J Huff, DHEd
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

Allison J. Huff
Tucson, Arizona, 85711
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Allison J Huff, DHEd, PRINCIPAL_INVESTIGATOR, University of Arizona

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 Date2023-06-01
Study Completion Date2023-10-11

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2023-10-11

Terms related to this study

Keywords Provided by Researchers

  • substance abuse
  • tDCS
  • substance use disorder
  • SUD

Additional Relevant MeSH Terms

  • Substance Use Disorders
  • Substance Abuse
  • Substance Use