NCT05074524

Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder
• Heroin Abuse
• Craving
• Transcranial Magnetic Stimulation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-01-24
• Completion: 2022-01-24
• First posted: 2021-10-12
• Last updated: 2022-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study