CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 218 enrolled
Drug / intervention
Tolcapone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01001520
NCT01001520Phase 2Completed

Neural Substrates of Cognitive Deficits in Nicotine Withdrawal

University of Pennsylvania·interventional·Posted Oct 26, 2009·Updated Jul 2, 2014

In Brief

A Phase 2 clinical trial evaluating Tolcapone and Placebo for Tobacco Use Disorder. Completed, enrolled 218 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 26, 2009
Enrollment StartJan 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.7 years ago

Interventions

Tolcaponedrug

Participants will be asked to take study medication each day for both 11-day study medication periods. The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period.

Placebodrug

Participants will be asked to take study medication each day for both 11-day study medication periods. The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period.