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Treatment for Nicotine Addiction in Women

NCT ID: NCT02448654

Last Updated: 2020-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-23

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tolcapone

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

Group Type ACTIVE_COMPARATOR

Sugar Pill

Intervention Type DRUG

The sugar pill (placebo) will be compared to tolcapone

Sugar Pill

Sugar pill

Group Type PLACEBO_COMPARATOR

Tolcapone

Intervention Type DRUG

Tolcapone will be compared to sugar pill

Interventions

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Tolcapone

Tolcapone will be compared to sugar pill

Intervention Type DRUG

Sugar Pill

The sugar pill (placebo) will be compared to tolcapone

Intervention Type DRUG

Other Intervention Names

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Tasmar Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise DeVito, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Veterans Administration Hospital

West Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R21DA038253-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1504015628

Identifier Type: -

Identifier Source: org_study_id