Treatment for Nicotine Addiction in Women

Yale University

Status: Completed

Conditions: Nicotine Dependence

Treatments: Drug: Tolcapone; Drug: Sugar Pill

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02448654

1R21DA038253-01A1 (U.S. NIH Grant/Contract)

1504015628

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Tolcapone

Active Comparator group

Description:

100mg tolcapone three times a day for 7 days then 100mg once a day on day 8

Treatment:

Drug: Sugar Pill

Sugar Pill

Placebo Comparator group

Description:

Sugar pill

Treatment:

Drug: Tolcapone