Brain Stimulation for Nicotine Addiction in Schizophrenia

N/A

Recruiting

Led By Heather B Ward, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to one week, and three weeks to five weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare two types of brain stimulation in nicotine users with and without psychosis to see if it can change brain connections related to nicotine use and if it affects cravings. Participants will undergo cognitive tests

Who is the study for?

This trial is for individuals who use nicotine and have schizophrenia, as well as those without a psychotic disorder. Participants should be interested in how brain stimulation might help with nicotine cravings.

What is being tested?

The study tests two types of transcranial magnetic stimulation (rTMS) to see if they can alter brain activity related to nicotine use and reduce cravings. It compares the effects on people with and without psychosis.

What are the potential side effects?

rTMS may cause discomfort at the site of application, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and temporary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to one week, and three weeks to five weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to one week, and three weeks to five weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one week, and three weeks to five weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cue-induced craving

Resting-state functional connectivity

Self-reported craving

+1 more

Secondary study objectives

Fagerstrom Test for Nicotine Dependence (FTND)

Self-reported nicotine use

Wisconsin Smoking Withdrawal Scale (WSWS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: L DLPFC-Targeted iTBS, Then DMN-Targeted cTBSActive Control1 Intervention

Participants will first receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the DMN-Targeted cTBS. Participants will then receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses.

Group II: DMN-Targeted cTBS, Then L DLPFC-Targeted iTBSActive Control1 Intervention

Participants will first receive continuous theta burst stimulation (cTBS) at 100% AMT targeted to an individual-specific map of the left parietal node of the default mode network for five consecutive days. cTBS will be administered in a pattern consisting of 1 60s train of 3 pulses at 50Hz, repeated at 5Hz, for a total of 600 pulses. There will then be a washout period of at least two weeks before starting the L DLPFC-Targeted iTBS. Participants will receive intermittent theta burst stimulation (iTBS) at 100% active motor threshold (AMT) anatomically targeted to the left dorsolateral prefrontal cortex for five consecutive days. iTBS will be administered in a pattern consisting of 2s trains of 3 pulses at 50Hz, repeated at 5Hz, every 10s for a total of 600 pulses.

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