West Haven, Connecticut 06516


Purpose:

The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.


Study summary:

The proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the COMT inhibitor, tolcapone, in nicotine dependent women. This study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. Withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. Smoking urges will be assessed by a self-report scale.


Criteria:

Inclusion Criteria: - Must be 18yrs to 45yr old woman, read and write in English. - Must smoke at least 5 or more cigarettes a day - FTND score at least 4 or higher - A CO reading of 10 or higher during screening - Must be in good health as verified by medical history, screening exam, screen laboratory tests. Exclusion Criteria: - Excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.


NCT ID:

NCT02448654


Primary Contact:

Principal Investigator
Elise DeVito, Ph.D.
Yale University

Elise DeVito, Ph.D.
Phone: 203-737-4882
Email: elise.devito@yale.edu


Backup Contact:

Email: mehmet.sofuoglu@yale.edu
Mehmet Sofuoglu, M.D., Ph.D.
Phone: 203-937-4809


Location Contact:

West Haven, Connecticut 06516
United States

Elise DeVito, Ph.D.
Phone: 203-737-4882
Email: elise.devito@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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