Clinical trial NCT05295953: Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
Official title: Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Tobacco Smoking
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-03-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active group and sham group
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gaze Fixation on Smoking Cues
timeFrame: On Day 1 of the study
measure: Gaze Fixation on Smoking Cues
timeFrame: On Day 1 of the study after intervention
measure: Craving for cigarettes
timeFrame: On day one of the study.
measure: Craving for cigarettes
timeFrame: Immediately after intervention (sessions of TBS or sham TMS) on day 1
Secondary outcomes:
measure: Functional connectivity changes
timeFrame: on Day 1 of study
measure: Functional connectivity changes
timeFrame: Immediately after intervention (sessions of TBS or sham TMS) on day 1
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 245 Fountain Court
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: