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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00944554
Other study ID # NA_00019900
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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