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Completed

NCT Number: NCT00944554

Relapse Prevention With Varenicline

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.

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Key information

Conditions

Recurrence Behavior Chemically-Induced Disorders Disease Attributes Health Behavior Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Smoking Cessation Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

About this study

In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Varenicline

Drug

Varenicline given twice a day or five weeks.

Other names: Varenicline (Chantix®)

Placebo

Drug

Placebo given twice a day or five weeks.

Primary outcomes

  1. Days to Relapse

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Pfizer

Registry information

Acronym: 0815

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2009
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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