NCT00580853

Brief Summary

The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_2

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

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

February 8, 2018

Status Verified

January 1, 2018

Enrollment Period

9.5 years

First QC Date

December 25, 2007

Results QC Date

October 21, 2016

Last Update Submit

January 12, 2018

Conditions

Smoking Lapse Behavior

Keywords

smoking lapse behaviorsmoking cessationvareniclinebupropionmedication effect on smoking lapse behavior

Outcome Measures

Primary Outcomes (1)

  • Latency to Initiate Ad-lib Smoking Session

    minutes to start smoking (range 0 to 50 minutes)

    0 to 50 minutes

Secondary Outcomes (1)

  • Number of Cigarettes Smoked During the 60 Minute Ad-lib Period

    60 minutes

Study Arms (3)

varenicline

EXPERIMENTAL

varenicline 2mg/day

Drug: varenicline

Bupropion

EXPERIMENTAL

Bupropion 300mg/day

Drug: bupropion

Placebo

PLACEBO COMPARATOR

Placebo Control

Drug: Placebo

Interventions

vareniclineDRUG

2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).

Also known as: Chantix
varenicline
bupropionDRUG

300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).

Also known as: Zyban
Bupropion
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-55
  • able to read and write in English
  • Smokers

You may not qualify if:

  • any significant current medical or psychiatric conditions that would contraindicate smoking
  • current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
  • positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
  • women who are pregnant or nursing
  • suicidal, homicidal, or evidence of current severe mental illness
  • participants prescribed any psychotropic drug in the 30 days prior to study enrollment
  • blood donation within the past 6 weeks
  • individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
  • known allergy to varenicline or taking H2blockers
  • participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

VareniclineBupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesPropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Sherry McKee PhD
Organization
Yale University
sherry.mckee@yale.edu
203-737-3529

Study Officials

  • Sherry A McKee, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2007

First Posted

December 27, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 8, 2018

Results First Posted

March 10, 2017

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)