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

Gopalkumar Rakesh

Status: Completed

Conditions: Tobacco Smoking; Hiv

Treatments: Device: Sham TMS; Device: TBS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05295953

70889

5P30CA177558-10 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 2 patient groups, including a placebo group

TBS (Theta burst stimulation)

Active Comparator group

Description:

Four sessions of TBS in one day

Treatment:

Device: TBS

Sham TMS

Placebo Comparator group

Description:

Four sessions of sham TMS

Treatment:

Device: Sham TMS