Adults 22 to 60, any sex, with Cocaine Use Disorder or Cocaine Dependence. 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.
Number of Cocaine Dependent Participants Who Tolerated Intermittent Theta-Burst Stimulation SessionsPrimary· Up to 10 days of treatment
Number of cocaine dependent participants who tolerated the intermittent Theta-Burst Stimulation (iTBS) treatment. Participants in the pilot group had a maximum of 2 weeks and participants in the EFS group had a maximum of three weeks to complete the 10 days of treatment.
Group
Value
95% CI
Pilot Group
9
Expanded Feasibility Study (EFS): Cocaine - Active Group
1
Change in Brain Global Efficiency After Day One of Intermittent Theta-Burst Stimulation Treatment (Acute Effect)Primary· pre/post treatment day 1.
Participants received resting brain fMRI scan followed by three iTBS sessions then a second brain fMRI scan. Analysis was done to determine if iTBS alters brain networks and calculated as the difference between global efficiency (GE) before and after the first day of iTBS (pre-post). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connect
Group
Value
95% CI
Expanded Feasibility Study (EFS): Cocaine - Active Group
-0.03716097
± 0
Expanded Feasibility Study (EFS): Cocaine - Sham Group
0.004610517
± 0.003557275
Expanded Feasibility Study (EFS): Healthy Control - Active Treatment
-.01535
± 0.032982662
Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment
-0.008708172
± 0.021423157
Change in Brain Global Efficiency After Intermittent Theta-Burst Stimulation Treatment (iTBS) Course (Chronic Effect)Primary· Baseline (pre-treatment) minus two weeks post treatment
Participants received baseline resting brain fMRI scan on day one and had a repeat brain fMRI two weeks after iTBS treatment course. Analysis was done to determine change in brain network with chronic treatment in cocaine dependent participants and calculated as the difference between global efficiency (GE) from baseline to post treatment (2 weeks after end of treatment). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across differe
Group
Value
95% CI
Expanded Feasibility Study (EFS): Cocaine - Active Group
-0.009259302
± 0
Expanded Feasibility Study (EFS): Cocaine - Sham Group
-0.021988865
± 0.009881832
Brain Global Efficiency Before Intermittent Theta-Burst Stimulation Treatment (iTBS)Primary· Baseline (pre-treatment)
The brain global efficiency for cocaine dependent participants and healthy control participants at baseline (pre-treatment), prior to intermittent Theta-Burst Stimulation Treatment (iTBS). Global efficiency is a graph-theory measure that indicates how well information can be transferred across the entire brain network. A high global efficiency indicates that information can be rapidly transmitted across different brain regions due to short average path lengths between them, suggesting a well-connected and integrated brain network. It is calculated by defining N nodes and calculating the shorte
Group
Value
95% CI
Expanded Feasibility Study (EFS): Cocaine Dependent Participants
0.370168044
± 0.070814395
Expanded Feasibility Study (EFS): Healthy Control
0.328063781
± 0.035358035
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants in the pilot phase were followed for 6 weeks. Cocaine dependent participants in the Expanded Feasibility Study (EFS) phase were followed for 6 months. Control participants in the EFS phase were participated for about two weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pilot Group
Serious: 0/19 (0%)
Deaths: 0/19
Expanded Feasibility Study (EFS): Cocaine - Active Group
Serious: 0/4 (0%)
Deaths: 0/4
Expanded Feasibility Study (EFS): Cocaine - Sham Group
Serious: 0/3 (0%)
Deaths: 0/3
Expanded Feasibility Study (EFS): Healthy Control - Active Treatment Intervention
Serious: 0/19 (0%)
Deaths: 0/19
Expanded Feasibility Study (EFS): Healthy Control - Sham Treatment Intervention
Objective: The goal of this clinical trial is to assess the tolerability of an accelerated intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation, intervention in participants with cocaine use disorder and then to determine if the intervention changes brain circuits related to cocaine use disorder and whether these changes relate to clinical outcomes.
The main questions it aims to answer are:
* Can individuals with cocaine use disorder tolerate accelerated iTBS (3 treatments per day for 10 days) (Pilot study)?
* Does iTBS (compared to sham iTBS) alter brain circuits related to cocaine use disorder (Expanded feasibility study)?
Researchers will compare individuals with cocaine use disorder to those without cocaine use disorder to identify differences at baseline, compare effects of the first day of iTBS treatment, and see if changes after treatment align brain circuits in those with cocaine use disorder more closely to patterns seen in those without cocaine use disorder.
Participants will:
* Undergo 10 days of iTBS treatment and two follow-up visits (1 week and 4 weeks after treatment) and complete questionnaires throughout to assess tolerability and drug use (Pilot study).
* Participants with cocaine use disorder will complete a characterization phase with questionnaires, two fMRI scans and a trial session of iTBS (sham or active) before the treatment phase (Expanded feasibility study).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Transcranial magnetic stimulation (TMS)
Trials testing the same drug.
NCT07397897 — Intracranial EEG to Test How Noninvasive Stimulation Affects Hippocampal-dependent Memory
· NA
· enrolling by invitation
NCT06503523 — The Effects of Performing a Motor Imagery Task on Cortical Excitability During Acute Experimental Muscle Pain and Acute
· NA
· recruiting
NCT06470737 — Investigation of Corticospinal Excitability Aspects of Itch and Pain
· NA
· completed
NCT05829005 — Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study
· NA
· completed
NCT05713721 — Sensorimotor Integration in Monogenic Parkinson-dystonia Syndromes
· unknown
Other recruiting trials for Cocaine Use Disorder
Currently open trials in the same condition.
NCT07227948 — Repurposing Semaglutide for the Treatment of Cocaine Use Disorder
· Phase 2
· recruiting
NCT07086794 — Cocaine and Pentoxifylline (BED IN 47)
· EARLY_PHASE1
· recruiting
NCT06050304 — CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations
· NA
· recruiting
NCT07091877 — Cocaine Cue-reactivity Incubation Study
· NA
· recruiting
NCT05986578 — Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
· NA
· recruiting
Other National Institute on Drug Abuse (NIDA) trials
Trials by the same sponsor.
NCT07468552 — Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
· Phase 2
· not yet recruiting
NCT06808932 — VK4-116 Phase I Study With Food-Effect
· Phase 1
· not yet recruiting
NCT06676059 — SMART-r: Substance Monitoring and Active Relapse Tracking Repository
· recruiting
NCT06577454 — Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Sub
· NA
· suspended
NCT06868914 — Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA)
Last refreshed: 25 February 2025
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/NCT02927236.