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

NCT ID: NCT05295953

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-07-31

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.

Conditions

Hiv; Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TBS (Theta burst stimulation)

Four sessions of TBS in one day

Group Type: ACTIVE_COMPARATOR

TBS

Intervention Type: DEVICE

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

Group Type: PLACEBO_COMPARATOR

Sham TMS

Intervention Type: DEVICE

Four sessions of sham TMS delivered using MagVenture B65 A/P coil.

Interventions

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.

Intervention Type: DEVICE

Sham TMS

Four sessions of sham TMS delivered using MagVenture B65 A/P coil.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

245 Fountain Court

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

References

Rakesh G, Alcorn JL 3rd, Khanal R, Himelhoch SS, Rush CR. Comparing cigarette-cue attentional bias between people with HIV/AIDS and people with opioid use disorder who smoke. Health Psychol Behav Med. 2023 Sep 7;11(1):2255028. doi: 10.1080/21642850.2023.2255028. eCollection 2023.

Reference Type: DERIVED

PMID: 37693107 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30CA177558-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

70889

Identifier Type: -

Identifier Source: org_study_id