NCT00944554

Brief Summary

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2008

Typical duration 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

October 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2017

Completed
Last Updated

August 3, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

July 21, 2009

Results QC Date

April 20, 2017

Last Update Submit

July 28, 2017

Conditions

RecurrenceSmoking CessationSubstance-Related Disorders

Keywords

RelapseSmoking CessationSubstance Abuse

Outcome Measures

Primary Outcomes (1)

  • Days to Relapse

    Number of days following the programmed lapse exposure until relapse to smoking occurred

    4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Group given placebo.

Drug: Placebo

Varenicline

EXPERIMENTAL

Experimental group given varenicline dosing.

Drug: Varenicline

Interventions

VareniclineDRUG

Varenicline given twice a day or five weeks.

Also known as: Varenicline (Chantix®)
Varenicline
PlaceboDRUG

Placebo given twice a day or five weeks.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years old
  • Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
  • Contemplating a smoking cessation attempt in the near future
  • Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
  • Able to give informed consent

You may not qualify if:

  • Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
  • History of attempted suicide or expresses any current suicidal ideation
  • Pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • Reports desire for immediate treatment of tobacco/nicotine dependence
  • Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

RecurrenceSmoking CessationSubstance-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Experimental model of relapse used in non-treatment seeking smokers. Results may not generalize to all smokers.

Results Point of Contact

Title
Maxine Stitzer, PhD
Organization
Johns Hopkins University
mstitze1@jhmi.edu
410-550-0042

Study Officials

  • Maxine L Stitzer, PhD

    Johns Hopkins University

    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, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 3, 2017

Results First Posted

June 23, 2017

Record last verified: 2017-07

Locations

US(1)