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Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

NCT05049460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-10-22

Study results available
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Summary

The goal of this study is to examine the effect of four sessions of theta burst stimulation (TBS) versus sham TMS on attentional bias for smoking and opioid cues versus neutral stimuli in a population of patients with tobacco use disorder (TUD) with comorbid opioid use disorder (OUD) that is stable and on treatment with buprenorphine. The investigators will also examine the effect of TBS on craving for cigarettes as well as opioids. Participants will perform a stress induction procedure that mirrors an optimum combination of cues that trigger tonic craving in their environment while exposed to stress. All four sessions of TBS/sham TMS will be performed on the same day, with each session lasting for approximately 10 minutes and separated by 50 minute intervals.

Conditions

  • Opioid-use Disorder
  • Tobacco Use Disorder

Interventions

DEVICE

Theta Burst Stimulation

Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.

DEVICE

Sham TMS

Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.

Sponsors & Collaborators

  • Gopalkumar Rakesh

    lead OTHER

Principal Investigators

  • Craig Rush, PhD · Professor, Department of Behavioral Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Device
Yes

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 NCT05049460 on ClinicalTrials.gov