Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
NCT05074524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-05-17
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.
Conditions
- Opioid-use Disorder
- Heroin Abuse
- Craving
- Transcranial Magnetic Stimulation
Interventions
- 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.
Sponsors & Collaborators
-
University of Nevada, Las Vegas
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-06
- Primary Completion
- 2022-01-24
- Completion
- 2022-01-24
- FDA Device
- Yes
Countries
- United States
Study Locations
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