Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04883021 |
| Other study ID # |
UNM HRRC# 20-077 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
We propose a single-arm clinical trial, with historical controls as a comparison group for
select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst
stimulation to the DLPFC and MPFC over 4 weeks. We will follow outcomes for 12 weeks.
Outcomes include treatment retention, craving, self-reported MA or stimulant use, urine drug
screen results, depressive symptoms, anxiety symptoms, sleep quality, quality of life,
response inhibition, and functional connectivity. Magnetic resonance imaging (MRI) to measure
functional connectivity at baseline and four weeks.
Description:
Methamphetamine (MA) use can cause many serious adverse health consequences and is an
important public health issue in Iowa, New Mexico, and Utah. In the 2017 Treatment Episode
Data Set, 26% of substance use disorder treatment admissions from these states involved MA as
the primary substance. MA-involved overdose deaths have been increasingly common in these
states. Treatment for MA use disorder (MAUD) is primarily psychosocial. Rates of treatment
induction and retention are poor, and relapse rates are high. There is a pressing need to
identify effective interventions that enhance psychosocial treatments.
Transcranial magnetic stimulation (TMS) using either high frequency stimulation or
intermittent theta burst stimulation is a non-invasive brain stimulation technique that
effectively treats major depressive disorder and is considered safe, well-tolerated, and
potent. TMS has increasingly been studied to treat addiction. The dorsolateral prefrontal
cortex (DLPFC), a brain region implicated in regulatory processes related to executive
function, emotion, motivation, and craving, is a common target for TMS. DLPFC stimulation
using high frequency repetitive TMS has reduced craving in many studies of addictive
disorders, including cocaine and MAUD. In addition to the DLPFC target, emerging evidence
indicates that continuous theta burst stimulation (cTBS) delivered to the medial prefontal
cortex (MPFC) during drug cue activation reduced craving and related brain activity in
cocaine users. Despite these encouraging findings, no trials have reported on the efficacy of
TMS for reducing MA use or preventing relapse. Clinical research on TMS for MAUD is sparse in
the United States, and the limited studies of TMS in MAUD have been in experimental or closed
treatment settings where effects on actual MA use are difficult to evaluate.
We are proposing a pilot study in 8 people with MAUD engaged in psychosocial treatment to
explore the effects and tolerability of a four-week treatment protocol combining intermittent
theta burst stimulation of the DLPFC with cTBS targeting the MPFC (dual-target TMS). We
expect that this combined approach will enhance executive function and inhibitory control and
reduce craving through separate but related mechanisms. We will evaluate clinical outcomes
including symptoms and substance use, changes in functional connectivity measured via MRI and
their relationship to treatment response, and changes in impulsivity as measured by
performance on a response inhibition task. This project has the following specific aims:
Aim 1: Characterize changes in craving, depressive symptoms, anxiety symptoms, sleep quality,
quality of life, and MA or other stimulant use over four weeks of dual-target TMS and eight
weeks of subsequent follow-up.
Aim 2: Estimate changes in functional connectivity in the brain and response inhibition and
selective attention in people with MAUD after four weeks of dual-target TMS.
Aim 3: Evaluate retention in the study to establish feasibility and tolerability of the
protocol.
Aim 4: Compare retention in psychosocial treatment and positive urine drug screens in study
participants compared to matched historical controls.
