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Transcranial Stimulation for Opioid Use Disorder

N/A

Recruiting

Research Sponsored by Gopalkumar Rakesh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stabilized on maintenance buprenorphine if having comorbid opioid use disorder

Aged 18-60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after intervention (sessions of tbs or sham tms)

Awards & highlights

Study Summary

This trial is examining the effect of four sessions of theta burst stimulation (TBS) 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).

Who is the study for?

This trial is for adults aged 18-60 who smoke at least 10 cigarettes daily or score >5 on a nicotine dependence test, and are stable on buprenorphine for opioid use disorder. They must be right-handed, able to abstain from drugs, have low breath CO levels, speak English, give consent, and attend the SMART Clinic at University of Kentucky.Check my eligibility

What is being tested?

The study tests if theta burst stimulation (TBS), a type of brain stimulation therapy, can reduce cravings and attentional bias towards smoking and opioid cues compared to sham TMS (a placebo-like procedure). Participants will undergo four sessions in one day with stress-inducing tasks that mimic real-life craving triggers.See study design

What are the potential side effects?

While not explicitly stated here, TBS may cause discomfort at the stimulation site, headache or lightheadedness. Sham TMS should have no active side effects but might include similar sensations due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a stable dose of buprenorphine for opioid addiction.

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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after intervention (sessions of tbs or sham tms)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after intervention (sessions of tbs or sham tms)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after intervention (sessions of tbs or sham tms) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attentional bias for opioid stimuli

Attentional bias for smoking stimuli

Craving

Secondary outcome measures

Functional connectivity changes

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active interventionActive Control1 Intervention

Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan.

Group II: Sham TMSPlacebo Group1 Intervention

Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Gopalkumar RakeshLead Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Craig Rush, PhDStudy ChairProfessor, Department of Behavioral Sciences

1 Previous Clinical Trials

19 Total Patients Enrolled

Media Library

Active intervention Clinical Trial Eligibility Overview. Trial Name: NCT05049460 — N/A

Tobacco Use Disorder Research Study Groups: Active intervention, Sham TMS

Tobacco Use Disorder Clinical Trial 2023: Active intervention Highlights & Side Effects. Trial Name: NCT05049460 — N/A

Active intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049460 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any capacity to join this experiment?

"Affirmative. The evidence provided by clinicaltrials.gov indicates that this trial is currently seeking participants, having been posted on September 15th 2021 and subsequently updated November 7th 2022. This specific study necessitates the enrollment of 40 subjects from a single site."

Answered by AI

Who can be considered an eligible participant in this clinical trial?

"This research requires 40 individuals with a tobacco dependency aged between 18 and 60. To qualify, they must be attending the SMART Clinic at University of Kentucky, abstain from all drug use, smoke 10 or more cigarettes daily, or have an Fagerstrom Test for Nicotine score above 5."

Answered by AI

What is the aggregate amount of individuals involved in this trial?

"Affirmative. According to the official listing on clinicaltrials.gov, this study is open for recruitment and was initially uploaded on September 15th 2021. Most recently updated in November 7th 2022, it seeks 40 participants from a single location."

Answered by AI

Are elderly individuals qualified to participate in the experiment?

"The requirements for this clinical trial specify that participants must be between 18-60 years old. By contrast, there are 271 trials dedicated to minors and 879 tailored towards elderly individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

Gopalkumar Rakesh 2021. "Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049460.