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Status:

COMPLETED

Effect of Galantamine on Inflammation and Cognition

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

HIV Associated Cognitive Motor Complex

Eligibility:

All Genders

30+ years

Phase:

PHASE2

Brief Summary

This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers...

Detailed Description

Although anti-retroviral therapy (ART) enhances life expectancy and overall quality of life (QoL), HIV-infected individuals are increasingly vulnerable to non-AIDS-related diseases including HIV-assoc...

Eligibility Criteria

Inclusion

  • 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

  • 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 evaluated for clinical significance by the Study Physician and eligibility will determined on a case-by-case basis.
  • Renal disease or renal dysfunction (e.g., serum creatinine levels greater than 1.5 X upper limit of normal). Those with moderate hepatic impairment or creatinine clearance 9 to 59 mL/min shall not exceed the 16 mg/day dose.
  • Peptic ulcer disease (requires study physician approval)
  • Suicide risk as indicated by at least one of the following on the Columbia Suicide Severity Rating Scale (the PI and/or study psychologist will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):
  • Current suicidal ideation (within 30 days of enrollment)
  • Two or more lifetime suicide attempts or episodes of suicidal behavior
  • Any suicide attempt or suicidal behavior within 2 years of enrollment
  • Medication
  • Current use or discontinuation within the last 14 days of:
  • Quit smoking medications including varenicline (Chantix), bupropion (Wellbutrin)
  • Anti-psychotic medications (e.g., Zyprexa, Clozaril, Seroquel, Risperdal). If used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
  • Systemic Steroids (e.g., Prednisone).
  • Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine)
  • Irritable bowel syndrome medication (e.g., Dicyclomine/Bentyl)
  • Heart medications (e.g., quinidine).
  • Muscle relaxants (e.g., Anectine/succinylcholine)
  • Anti-seizure medications (e.g. Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topomax) if used to treat a seizure disorder or epilepsy. Other uses may be eligible.
  • Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/ phenoxybenzamine, Regitine/phentolamine)
  • Daily use of:
  • Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an "as-needed" basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement.
  • Chronic obstructive pulmonary disease (COPD) medication (e.g., Atrovent/Ipratropium Bromide)
  • Known allergy to study medication.
  • Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study.

Key Trial Info

Start Date :

October 30 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT03384784

Start Date

October 30 2017

End Date

May 31 2022

Last Update

October 17 2024

Active Locations (1)

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Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104