Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Hiv Clinical Trial

Official title:

Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295953
• Other study ID #: 70889
• Secondary ID: 5P30CA177558-10
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.

Description:

The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related morbidity, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria: Potential participants will be

• Patients enrolled in the Bluegrass Clinic

• 18-60 years of age

• Male or female gender

• Able to read, understand and communicate in English

• Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic

• Willing and able to abstain from drug use other than Suboxone

• Exhaled breath on day of study carbon monoxide (CO) < 5 ppm

• Stabilized on maintenance buprenorphine if having comorbid opioid use disorder.

Exclusion Criteria:

• Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.

• Previous adverse effect with TMS.

• Sub-threshold consistency while performing behavioral tasks.

• Failure to show baseline attentional bias to smoking versus neutral cues.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hiv
• HIV Infections
• Tobacco Smoking

Intervention

Device:
• TBS
Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.
• Sham TMS
Four sessions of sham TMS delivered using MagVenture B65 A/P coil.

Locations

Country	Name	City	State
United States	245 Fountain Court	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Gopalkumar Rakesh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gaze Fixation on Smoking Cues	Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome	On Day 1 of the study
Primary	Gaze Fixation on Smoking Cues	Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome	On Day 1 of the study after intervention
Primary	Craving for cigarettes	Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.	On day one of the study.
Primary	Craving for cigarettes	Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.	Immediately after intervention (sessions of TBS or sham TMS) on day 1
Secondary	Functional connectivity changes	Changes in functional connectivity measured using z score on functional MRI brain scan.	on Day 1 of study
Secondary	Functional connectivity changes	Changes in functional connectivity measured using z score on functional MRI brain scan.	Immediately after intervention (sessions of TBS or sham TMS) on day 1