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10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence

NCT03238859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-03-12

No results posted yet for this study

Summary

The goal of this double-blind sham controlled study is to evaluate the effeicacy of continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue reactivity and improve treatment outcomes in treatment-engaged cocaine and alcohol users. All participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole. Brain imaging data and behavioral assessments will be collected at 4 time points - before TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.

Conditions

  • Cocaine Dependence
  • Alcohol Dependence

Interventions

DEVICE

Real cTBS

This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)

DEVICE

Sham cTBS

This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Colleen A Hanlon, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-06-07
Completion
2019-06-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238859 on ClinicalTrials.gov