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NCT01001520 · ClinicalTrials.gov registry record · Phase 2

Neural Substrates in Nicotine Withdrawal

A Phase 2 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 2
Development phase
218
Enrollment target

NCT01001520: Completed Phase 2 study, sponsored by University of Pennsylvania.

NCT01001520 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 218 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01001520, a Phase 2 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 2
Development phase
218 participants
Enrollment target

Study Summary

This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar) will help reduce cognitive problems that smokers experience when they quit. This study will also determine whether the benefits of this medication differ depending on a smokers' genetic background.

Primary Outcome

Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the "N-back". This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black sc

Interventions

  • DRUG Placebo
  • DRUG Tolcapone

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2010-01
Est. Completion 2012-10
Phase Phase 2
University of Pennsylvania

1,423 total trials

What the finished NCT01001520 record still lists

NCT01001520 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01001520 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01001520 about?

NCT01001520 is a clinical study titled "Neural Substrates in Nicotine Withdrawal". This study will test the hypothesis that a medication called tolcapone (Brand Name: Tasmar) will help reduce cognitive problems that smokers experience when they quit. This study will also determine whether the benefits of this medication differ depending on a smokers' genetic background.

What is the current status of trial NCT01001520?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2010-01. Estimated completion is 2012-10.

What interventions are being tested in trial NCT01001520?

The interventions under investigation include: Placebo (DRUG), Tolcapone (DRUG).

Who is sponsoring clinical trial NCT01001520?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01001520's enrollment target sits among peer trials

218 284th of 2000 higher than 1,715 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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Source: ClinicalTrials.gov NCT01001520, the US trial registry maintained by the National Library of Medicine. NCT01001520 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.