NCT01228175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 4, 2016

Completed
Last Updated

May 9, 2018

Status Verified

April 1, 2018

Enrollment Period

4.9 years

First QC Date

September 8, 2010

Results QC Date

September 16, 2016

Last Update Submit

April 9, 2018

Conditions

Smoking Addiction

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 36 weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Varenicline

Drug: Varenicline

Microcrystal Cellulose

PLACEBO COMPARATOR

Microcrystal cellulose placebo

Drug: Placebo

Interventions

PlaceboDRUG

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

Also known as: riboflavin
Microcrystal Cellulose
VareniclineDRUG

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

Also known as: Chantix
Varenicline

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • yrs to 55 yrs
  • smoker

You may not qualify if:

  • Medical Contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Interventions

RiboflavinVarenicline

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological FactorsBenzazepinesQuinoxalines

Results Point of Contact

Title
Dr. Kent Hutchison
Organization
University of Colorado Boulder
kent.hutchison@colorado.edu
303-492-8163

Study Officials

  • Kent Hutchison, Ph.D

    Director, Neurogenetics Core, The Mind Research Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Science Officer

Study Record Dates

First Submitted

September 8, 2010

First Posted

October 26, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2015

Study Completion

March 1, 2016

Last Updated

May 9, 2018

Results First Posted

November 4, 2016

Record last verified: 2018-04

Locations

US(1)