Effectiveness of Varenicline: Testing Individual Differences

NCT ID: NCT01228175

Last Updated: 2018-05-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-03-31

Brief Summary

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The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.

Detailed Description

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Conditions

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Smoking Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Varenicline

Varenicline

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Microcrystal Cellulose

Microcrystal cellulose placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

25mg look alike riboflavin tablets to match active study medication.

Interventions

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Placebo

25mg look alike riboflavin tablets to match active study medication.

Intervention Type DRUG

Varenicline

Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Intervention Type DRUG

Other Intervention Names

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riboflavin Chantix

Eligibility Criteria

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Inclusion Criteria

* 18 yrs to 55 yrs
* smoker

Exclusion Criteria

* Medical Contraindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Mind Research Network

OTHER

Sponsor Role lead

Responsible Party

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Kent Hutchison, Ph.D.

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kent Hutchison, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Director, Neurogenetics Core, The Mind Research Network

Locations

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The Mind Research Network

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA025074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA025074

Identifier Type: NIH

Identifier Source: org_study_id

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