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Clinical Trials/NCT05074524
NCT05074524
Completed
N/A

Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin

University of Nevada, Las Vegas1 site in 1 country24 target enrollmentOctober 6, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
University of Nevada, Las Vegas
Enrollment
24
Locations
1
Primary Endpoint
Desires for Drug Questionnaire
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.

Detailed Description

This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.

Registry
clinicaltrials.gov
Start Date
October 6, 2021
End Date
January 24, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyunhwa Lee

Assistant Professor

University of Nevada, Las Vegas

Eligibility Criteria

Inclusion Criteria

  • Adult aged 18-64, used heroin in the past 30 days;
  • has a history of heroin use for at least one year;
  • meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
  • meets the clinician clearance using the rTMS Patient Screening Form.

Exclusion Criteria

  • do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
  • do not have a psychotic disorder;
  • do not have a diagnosis of another substance use disorder;
  • do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
  • do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
  • do not have a presence of non-fixed metal in body 30 cm to treatment coil.
  • have not taken any medication for a substance use disorder within the last 72 hours before the first rTMS treatment;
  • are not pregnant or think you may be pregnant.

Outcomes

Primary Outcomes

Desires for Drug Questionnaire

Time Frame: Days 1, 3, 5, 8, 10, 12, 42

This standardized questionnaire measures cravings for opioids. This scale includes a total of 13 items. Scoring is based on a 1-7 likert scale for each item. Specific items are assigned to one of three domains: desire, negative reinforcement, and control. A higher score indicates higher level of cravings. A lower score indicates a lesser level of opioid cravings, which is a better outcome. The primary outcome measure will be measured at various time points throughout the study to assess a change.

Study Sites (1)

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