CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
iTBS to dmPFC +1 moredevice
Likely dose
Not stated in record
Key inclusion· 1
  • Diagnosis of cocaine use disorder (CUD)
Key exclusion· 6
  • Moderate or severe substance use criteria for substances other than cocaine, cannabis, or nicotine
  • Unstable psychiatric disorder
  • Medical conditions contraindicated to TMS including medical implants, history of seizure or seizure disorder, medications lowering seizure threshold, neurological conditions, or moderate-to-severe heart disease
  • Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05631548
NCT05631548N/ACompleted

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

The University of Texas Health Science Center, Houston·interventional·Posted Nov 30, 2022·Updated Jan 31, 2024

In Brief

A clinical study evaluating iTBS to dmPFC and Sham iTBS for Cocaine Use Disorder. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 30, 2022
Enrollment StartFeb 23, 2023
Primary CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.6 years ago

Interventions

iTBS to dmPFCdevice

TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. Approximately 25% of the nasion-inion distance, or Talairah coordinates X 0 Y+60 Z+60 will be measured.The first session will begin with the acquisition of the resting motor threshold (rMT; lowest stimulus intensity that elicits a visible twitch on 50% of the trials) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last about 3 minutes. Each participant will receive 2 sessions with a 15-20 minute interval between sessions.

Sham iTBSdevice

Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 2 sessions with a 15-20 min interval between sessions.