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Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

Primary Purpose

Smoking Addiction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Varenicline
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Addiction

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 yrs to 55 yrs
  • smoker

Exclusion Criteria:

  • Medical Contraindications

Sites / Locations

  • The Mind Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline

Microcrystal Cellulose

Arm Description

Varenicline

Microcrystal cellulose placebo

Outcomes

Primary Outcome Measures

Cigarettes Per Smoking Day
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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2010
Last Updated
April 9, 2018
Sponsor
The Mind Research Network
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01228175
Brief Title
Effectiveness of Varenicline: Testing Individual Differences
Acronym
Varenicline
Official Title
Effectiveness of Varenicline: Testing Individual Differences
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Mind Research Network
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Active Comparator
Arm Description
Varenicline
Arm Title
Microcrystal Cellulose
Arm Type
Placebo Comparator
Arm Description
Microcrystal cellulose placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
riboflavin
Intervention Description
25mg look alike riboflavin tablets to match active study medication.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Primary Outcome Measure Information:
Title
Cigarettes Per Smoking Day
Description
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.
Time Frame
up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 yrs to 55 yrs smoker Exclusion Criteria: Medical Contraindications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Hutchison, Ph.D
Organizational Affiliation
Director, Neurogenetics Core, The Mind Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Varenicline: Testing Individual Differences

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