Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

April 9, 2018 updated by: Kent Hutchison, Ph.D., The Mind Research Network
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • The Mind Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 yrs to 55 yrs
  • smoker

Exclusion Criteria:

  • Medical Contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Varenicline
Drug: Varenicline
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Other Names:
  • Chantix
Placebo Comparator: Microcrystal Cellulose
Microcrystal cellulose placebo
Drug: Placebo
25mg look alike riboflavin tablets to match active study medication.
Other Names:
  • riboflavin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cigarettes Per Smoking Day
Time Frame: up to 36 weeks
The number of cigarettes smoked were assessed only on a "smoking day", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.
up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mind Research Network

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kent Hutchison, Ph.D, Director, Neurogenetics Core, The Mind Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA025074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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