NCT00602927

Brief Summary

This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

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

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 2, 2011

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

January 15, 2008

Results QC Date

October 6, 2010

Last Update Submit

May 6, 2011

Conditions

Nicotine Dependence

Keywords

Varenicline, Imaging, fMRI

Outcome Measures

Primary Outcomes (1)

  • Percent Change BOLD Signal

    We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.

    Day 13

Secondary Outcomes (1)

  • Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)

    Day 13

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Varenicline

ACTIVE COMPARATOR
Drug: Varenicline

Interventions

VareniclineDRUG

Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily

Also known as: Chantix
Varenicline
PlaceboDRUG

Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment-seeking smokers between the ages of 18 and 65, that smoke at least 10 cigarettes/day for at least the past 6 months
  • Provide a baseline CO (carbon monoxide) reading of \>10ppm
  • Provide written informed consent and are fluent, English-speaking
  • Weight of equal to or less than 300 lbs

You may not qualify if:

  • Smoking Behavior
  • Use of chewing tobacco, snuff or cigars
  • Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
  • Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
  • Provide a baseline CO (carbon monoxide) reading ≤10 ppm
  • History of substance abuse and/or currently receiving treatment for substance abuse
  • Current alcohol consumption that exceeds 25 standard drinks/week
  • A breath alcohol concentration reading ≥ 0.01 at the H\&P (health \& physical) screening or either of the lab sessions
  • Prior use of Chantix
  • Current use or recent discontinuation (within last 14-days) of the following medications:
  • Any form of smoking cessation medication
  • Any form of anti-psychotic medications that includes:
  • antipsychotics,
  • atypical antipsychotics,
  • mood-stabilizers,
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tobacco Use Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Loughead J, Ray R, Wileyto EP, Ruparel K, Sanborn P, Siegel S, Gur RC, Lerman C. Effects of the alpha4beta2 partial agonist varenicline on brain activity and working memory in abstinent smokers. Biol Psychiatry. 2010 Apr 15;67(8):715-21. doi: 10.1016/j.biopsych.2010.01.016. Epub 2010 Mar 6.

    PMID: 20207347RESULT

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Dr. Caryn Lerman
Organization
University of Pennsylvania
clerman@mail.med.upenn.edu
215-746-7141

Study Officials

  • Caryn Lerman, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 10, 2011

Results First Posted

May 2, 2011

Record last verified: 2011-05

Locations

US(1)