Treatment for Nicotine Addiction in Women

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.

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.