Clinical trial NCT01756053
Conditions: Nicotine Addiction
Keywords: Smoking Tobacco
Sponsor: University of Pennsylvania
Start date: 2013-03-01; Completion date: 2014-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (\~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.

Detailed description:
This is a single-site, phase IIa, double-blind, within-subject, cross-over, human laboratory study. Subjects will be healthy, treatment-seeking female and male adult smokers, ages 18 to 65 years old. Subjects deemed eligible for participation after an Intake Visit (\~Day -7) will complete baseline assessments and receive period 1 medication (ABT-089 or placebo) at the Baseline Visit (Day 0). Subjects will take 40mg of ABT-089 or placebo, based on random assignment, every day for two identical 10-day study treatment periods.

Subjects will begin period 1 study medication on Day 1. On Days 3 and 5, subjects will complete in-clinic medication run-up and monitoring assessments. On Day 5, subjects will begin a \~24-hour period of mandatory abstinence from smoking. Day 6 is conducted in two parts. Part 1 will consist of confirmation of smoking abstinence, testing for abstinence-induced cognitive deficits and the collection of subjective assessments. Part 2 will begin with a programmed smoking lapse, after which the subjective rewarding value of the programmed lapse cigarette will be assessed. Before leaving the clinic on Day 6, subjects will receive brief cessation counseling and be instructed to try to remain abstinent from 10pm that evening until after the final Observation Visit on Day 10.

During the \~4-day monitored abstinence/observation phase, subjects will complete in-clinic observation visits (subjective assessments, medication adherence, etc.) on Days 7, 8, and 10.

After a \~3-week medication washout period and Period 2 Medication Pick-up Visit on \~Day 31, subjects will begin study medication (either ABT-089 or placebo; but will always be the opposite of the assigned study medication in period 1) and participate in period 2 of the study following the same procedures as period 1.

Arms: arm 1: During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.

Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules. arm 2: These are matched placebo capsules manufactured by the study drug supplier.

During both 10-day study medication periods (Days 1-10 \& Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.

Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules.
Interventions: intervention 1: ABT-089 intervention 2: Placebo
Intervention descriptions: intervention 1: Selective neuronal nicotinic receptor agonist. intervention 2: Matched placebo capsules supplied by study drug supplier.

Protocol documents: