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NCT01756053 · ClinicalTrials.gov registry record · Phase 2
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
A Phase 2 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01756053: Clinical Trial Phase 2 study, sponsored by University of Pennsylvania.
NCT01756053 is a Phase 2 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756053, a Phase 2 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
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 period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back)
Interventions
- DRUG Placebo
- DRUG ABT-089
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Why NCT01756053 stopped before completion
NCT01756053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01756053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01756053 about?
NCT01756053 is a clinical study titled "Effects of ABT-089 on Smoking Abstinence Symptoms and Reward". 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...
What is the current status of trial NCT01756053?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2013-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01756053?
The interventions under investigation include: Placebo (DRUG), ABT-089 (DRUG).
Who is sponsoring clinical trial NCT01756053?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01756053's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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