Smoking
Conditions
Keywords
HIV, nicotine, brain, smoking
Brief summary
People living with HIV-1 have high rates of cigarette smoking, which may be related to nicotinic interaction with HIV-1 infection and brain function levels. The proposed project aims to understand these pathways using translational brain imaging and HIV-1 reactivation studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects in HIV-1 infection from cellular to brain circuitry levels.
Detailed description
Smoking remains the leading cause of preventable morbidity and mortality in the United States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus hindering the development of more effective, targeted treatments. The study will directly address neurological complication of this HIV-associated comorbidity at the brain circuitry level using state-of-the-art imaging tools and methods.
Interventions
OTHERTobacco smoking and nicotine patch
Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects between ages 18-60 in good health 2. Ability to give written informed consent 3. For people living with HIV: should be diagnosed with HIV two years or more and on ART two years or more 4. For people living with HIV: should have achieved virologic suppression (defined as viral loads of ≤ 200 copies/ml), and without current signs of reactivation
Exclusion criteria
1. Inability to sign informed consent 2. Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner 3. Any major medical illnesses to include, but not limited to, uncontrolled high blood pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis as per medical history 4. Current substance-induced psychiatric disorders 5. Significant alcohol or other drug use, other than nicotine dependence or marijuana use 6. Gross structural abnormalities and/or have a history of syncope 7. Positive urine pregnancy tests 8. Any neurological illnesses to include, but not limited to, seizure disorders, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor, 9. For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and other opportunistic disease 10. For people living with HIV: on active treatment of hepatitis C virus (HCV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional and structural connectivity using magnetic resonance imaging (MRI) | one day | Resting functional MRI and diffusion imaging MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 reactivation | one day | HIV-1 viral protein p24 expression |
Countries
United States
Outcome results
None listed