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NCT03538444: ArTMS

Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder

Terminated NA Results posted Last updated 14 February 2022
What this trial tests

NA trial testing Repetitive Transcranial Magnetic Stimulation in Opiate Dependence in 7 participants. Terminated before completion.

Timeline
28 September 2018
Primary endpoint
1 May 2020
1 May 2020

Quick facts

Lead sponsorMedical University of South Carolina
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment7
Start date28 September 2018
Primary completion1 May 2020
Estimated completion1 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 65, any sex, with Opiate Dependence or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Opioid Craving (Want, Resist, Crave) Primary · Baseline and three days: Pre-assessment (day 1-prior to the first delivered rTMS treatment) compared to post assessment (AM of day4 the morning following the final of three days of rTMS)

Change in cue-induced craving ratings on 10 point Likert Scales. 0=Not at all; 10=Extremely How much do you WANT TO USE \_(opiate of choice)\_ right now? HOW HARD would it be for you TO RESIST USING\_(opiate of choice)\_ right now if it was offered to you? How much do you currently crave opiates? (scores on each of those questions are summed to be between 0 and 30 with 30 being the highest (and indicating the most craving).

GroupValue95% CI
Active rTMS0.7± 1.2
Sham rTMS16.7± 12.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1-month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active rTMS
Serious: 0/4 (0%)
Deaths: 0/4
Sham rTMS
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (1 terms — click to expand)

ReactionSystemActive rTMSSham rTMS
headacheNervous system disorders

Data from ClinicalTrials.gov NCT03538444 adverse events section.

Sponsor's own description

This double-blind, randomized, controlled trials will investigate the effect of accelerated, repeated transcranial magnetic stimulation on opiate craving and perceived pain .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder.
    Ward HB, Mosquera MJ, Suzuki J, Mariano TY. · · 2020 · cited 13× · PMID 32059080 · DOI 10.1111/ner.13108

Verify or expand the search:

Other trials of Repetitive Transcranial Magnetic Stimulation

Trials testing the same drug.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03538444.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing