Health TrialsbyHealthPanel

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

ConditionsSmoking CessationNicotine AddictionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorThe University of Texas Health Science Center, Houston

About this trial

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female between ages 22-65 years

Ability to give written informed consent

Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks

Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10.

Disqualifiers

Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.

Had smoking cessation treatment, clinical trial, or nicotine replacements within the past four weeks.

Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.

Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • active F8-coil delivered rTMS

    Device

    Multiple trains of rTMS in a day, for multiple days.

  • active H-coil delivered rTMS

    Device

    Multiple trains of rTMS in a day, for multiple days.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Active control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)

The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the TMS effect on smoking reduction/cessation.

Time frame
1 month
2

Cigarette per day

Cigarette per day (CPD) is measured to index smoking reduction and cessation.

Time frame
1 month

Secondary outcomes

1

Fagerstrom Test for Nicotine Dependence (FTND)

Fagerstrom Test for Nicotine Dependence (FTND) represents the severity of nicotine severity.

Time frame
1 month
2

nicotine/creatinine

nicotine/creatinine is a index of smoking status.

Time frame
1 month
3

End-expired carbon monoxide (CO)

End-expired CO measure is an instant measure of smoking status.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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