Relapse Prevention With Varenicline

NCT00944554

Last updated date
Study Location
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Recurrence, Smoking Cessation, Substance-Related Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Recurrence, Smoking Cessation, Substance-Related DisordersRelapse Prevention With Varenicline
NCT00944554
  1. Baltimore, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Relapse Prevention With Varenicline
Official Title  ICMJE Relapse Prevention With Varenicline
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Recurrence
  • Smoking Cessation
  • Substance-Related Disorders
Intervention  ICMJE
  • Drug: Varenicline
    Varenicline given twice a day or five weeks.
    Other Name: Varenicline (Chantix®)
  • Drug: Placebo
    Placebo given twice a day or five weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Group given placebo.
    Intervention: Drug: Placebo
  • Experimental: Varenicline
    Experimental group given varenicline dosing.
    Intervention: Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
104
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2009)
120
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944554
Other Study ID Numbers  ICMJE NA_00019900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Maxine L Stitzer, PhDJohns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP