Status:
WITHDRAWN
The Use of AVL-3288 to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Cognitive Change
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Single-center, randomized, double-blind, placebo-controlled, proof-of-principle study to evaluate potential cognitive benefits of a single oral dose of AVL-3288 (3 mg) in the presence and absence of t...
Detailed Description
Nicotinic acetylcholine receptor (nAChR) agonists such as nicotine have been shown to enhance cognitive performance, especially functions in the attention domain. Efforts have been made to develop sim...
Eligibility Criteria
Inclusion
- Aged 21-50 years.
- Male or female willing to use qualified methods of contraception for the study duration and up to 2 months after its end. Qualified methods are: intrauterine device, condoms, oral contraceptives, surgical sterilization of the subject or the partner at least one year in advance, or postmenopausal status of the female defined as at least two years without menstruation.
- No exposure to any nicotine-containing product in the last year.
- Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime.
- Normal or corrected to normal vision (at least 20/80).
- Body weight 110-220 lbs.
Exclusion
- Pregnant or breast-feeding.
- DSM Axis I mood, anxiety or psychotic disorder.
- Drug or alcohol abuse or dependence currently or in the last 2 years.
- Cardiovascular or cerebrovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities (see below).
- Uncontrolled hypertension (resting systolic BP \>150 or diastolic \>95 mm Hg).
- Hypotension (resting systolic BP below 90 or diastolic below 60).
- Significant kidney or liver impairment.
- Moderate to severe asthma.
- Type I diabetes.
- Gastrointestinal illness.
- Use of any prescription or over-the-counter medication except birth control or non-steroidal antiinflammatory drugs on an as-needed basis.
- History of or current neurological illnesses, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
- Learning disability, mental retardation, or any other condition that impedes cognition.
- Any surgeries requiring full anesthesia scheduled within 2 weeks of any of the study test sessions.
- Inability to perform the Rapid Visual Information Processing Task.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03281694
Start Date
May 1 2018
End Date
February 1 2019
Last Update
November 6 2024
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