Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings

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

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation; Opioid-use Disorder; Craving; Heroin Abuse
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Repetitive Transcranial Magnetic Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • University of Nevada, Las Vegas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: rTMS group; Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up.	Device: Repetitive Transcranial Magnetic Stimulation; Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up.
SHAM_COMPARATOR: Placebo Group; The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation.	Device: Sham Repetitive Transcranial Magnetic Stimulation; The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desires for Drug Questionnaire	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.	Days 1, 3, 5, 8, 10, 12, 42

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2021
• Primary Completion (ACTUAL): January 24, 2022
• Study Completion (ACTUAL): January 24, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (ACTUAL): October 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Heroin Dependence
• Other Study ID Numbers: 1748113-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes