NCT01756053

A Pilot Feasibility Study of the Effects of ABT-089 on Smoking Abstinence Symptoms and Reward

Terminated Phase 2 Results posted Last updated 23 October 2014

What this trial tests

Phase 2 trial testing ABT-089 in Nicotine Addiction in 17 participants. Terminated before completion.

Timeline

1 March 2013

Primary endpoint
1 January 2014

1 January 2014

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	17
Start date	1 March 2013
Primary completion	1 January 2014
Estimated completion	1 January 2014
Sites	1 location across United States

Drugs / interventions tested

• ABT-089 — full drug profile →
• Placebo

Conditions studied

• Nicotine Addiction — all drugs for Nicotine Addiction →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
  Time frame: Baseline (Day 0) and Test Day (Days 6 & 37)
  We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other
• Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
  Time frame: Baseline (Day 0) and Test Day (Days 6 & 37)
  We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.