CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Tolcapone +1 moredrug
Likely dose
Tolcapone 100mgfrom 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/NCT01202955
NCT01202955Phase 2Completed
CompareCT.gov

Pilot Study of Tolcapone Effects on Abstinence-Induced Cognitive Symptoms in Smokers

University of Pennsylvania·interventional·Posted Sep 16, 2010·Updated Sep 12, 2018

In Brief

A Phase 2 clinical trial evaluating Tolcapone and Placebo for Nicotine Dependence. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2010
Enrollment StartJul 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.8 years ago

Interventions

Tolcaponedrug

Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day

Placebodrug

Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day