Effect of Galantamine on Inflammation and Cognition

Inclusion Criteria

Eligible subjects will be males and females:

• At least 30 years old
• Diagnosed with HIV-1 infection
• On stable ART regimens (no changes to treatment within 4 weeks of Intake visit)
• Viral load of less than or equal to 200 copies/mL
• Current cluster of differentiation (CD4) counts greater than 200
• If current or past diagnosis of bipolar disorder, eligible if:
• No psychotic features
• Montgomery-Asberg Depression Rating Scale (MADRS): total score less than 8 (past 4 weeks), suicidal item score less than 1 (past 4 weeks)
• Young Mania Rating Scale (Y-MRS): total score less than 8 (past 4 weeks), irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)
• No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
• No aggressive or violent acts or behavior in the past 6 months
• Able to communicate in English and provide written informed consent
• Will be residing in the geographic area for at least 7 months
• Not currently trying to quit smoking
• Smoking Status
• Smokers (HIV+S) will report at least 5 instances of smoking per day, on average for the past year and provide a breath carbon monoxide (CO) sample greater than 5 ppm at Intake and at the beginning of each treatment period
• Non-smokers (HIV+NS) will report smoking fewer than 100 cigarettes in their lifetime, or less than 5 pack years of smoking and no cigarettes in the last year. They will self-report no current use of any tobacco or nicotine product and will provide a CO sample of less than 3 ppm at Intake and at the beginning of each treatment period. If CO sample does not reflect self-report, the PI will be consulted to determine eligibility.

Exclusion Criteria

Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.

Smoking Behavior

• Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
• Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
• Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.

Alcohol/Drug Use

• Current untreated and unstable diagnosis of substance abuse or dependence (if past use and if receiving treatment and stable for at least 30 days, eligible)
• Positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, ecstasy (MDMA), at Intake or Lab visits. Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or opiates (low level cut-off 300 ng/mL) and who are prescribed these medications will be reviewed on a case-by-case basis by the study physician and PIs (see Measures and Table 1 for details). Participants believed to have a false-positive result on the drug screen may continue in the study, with investigator approval.

Medical/Psychiatric Conditions

• Women who are pregnant, planning a pregnancy or lactating
• Current diagnosis of unstable and untreated major depression (if stable for at least 30 days, eligible)
• Current or past diagnosis of psychotic disorder
• Cancer diagnosis within the past 6 months (except basal cell carcinoma)
• Major heart disease or stroke within the past 6 months
• Uncontrolled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100).
• Medical conditions contraindicated for use with galantamine:
• Diagnosis of Alzheimer's disease or dementia
• Epilepsy or other seizure disorder
• Bladder outflow obstruction
• Active HCV co-infection (if cured, requires study physician approval)
• Liver function tests more than 20% outside of the normal range; Gamma-glutamyl transpeptidase (GGT) values more than 20% outside of the normal range. If Albumin/Globulin ratios are 20% outside of normal range the abnormal value will be ev