N/A
Completed N=8
TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)
Smoking Cessation · HIV · Craving
Source: ClinicalTrials.gov NCT04936594 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking — 1007.05; 566.89 milliseconds
Summary
The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in 40 people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. For the study, participants would perform two cognitive tasks and neuroimaging before and after the TMS and investigators would compare changes in these paradigms with TMS. The investigators will also get a point of contact urine drug screen before study initiation. The investigators will aim to recruit 20 subjects in each arm of our trial (total of 40) from the BlueGrass HIV Clinic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking |
1007.05; 566.89 | — |
| PRIMARY Change in Attentional Bias Sham Smoking |
884.60; 658.67 | — |
| PRIMARY Change in Attentional Bias iTBS Paraphernalia |
670.43; 443.10 | — |
| PRIMARY Change in Attentional Bias Sham Paraphernalia |
528.38; 307.56 | — |
| SECONDARY Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS |
55.88; 43.13 | — |
| SECONDARY Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham |
53.2; 48.40 | — |
Eligibility Criteria
Inclusion Criteria
- Patients enrolled in the Bluegrass Clinic
- Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic
- Age 18-60 years
- Preferably right hand dominant
- Currently self-report smoking 10 of more cigarettes per day or a score of > 5 on the Fagerstrom Test for Nicotine
- Willing and able to abstain from all drug use
- Exhaled breath on day of study Carbon Monoxide < 10 ppm
- Stabilized on maintenance buprenorphine if having comorbid opioid use disorder
- Able to read and speak English
- Able to provide informed consent to participate.
Exclusion Criteria
- Pregnant, nursing, or becoming pregnant during the study
- History of traumatic brain injury or seizures which are contraindications for transcranial magnetic stimulation (TMS)
- Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes which are all contraindications for TMS
- Presence of intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus nerve stimulation device which are all contraindications for magnetic resonance imaging
- Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, major neurocognitive disorder, Huntington chorea; multiple sclerosis which are all contraindications for TMS.
Data sourced from ClinicalTrials.gov (NCT04936594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.