Relapse Prevention With Varenicline

Smoking Cessation Clinical Trial

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Official title:

Relapse Prevention With Varenicline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944554
• Other study ID #: NA_00019900
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2009
• Last updated: July 28, 2017
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation
• Substance-Related Disorders

Intervention

Drug:
• Varenicline
Varenicline given twice a day or five weeks.
• Placebo
Placebo given twice a day or five weeks.

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days to Relapse	Number of days following the programmed lapse exposure until relapse to smoking occurred	4 weeks