The Use of AVL-3288 to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine

• Status: Withdrawn
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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 transdermal nicotine (7 mg/24 hrs) in healthy non-smokers, while monitoring the safety and tolerability of AVL-3288.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.