Back to resultsRelapse Prevention With Varenicline (0815)
Primary Purpose
Recurrence, Smoking Cessation, Substance-Related Disorders
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Recurrence focused on measuring Relapse, Smoking Cessation, Substance Abuse
Eligibility Criteria
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)
Sites / Locations
- Behavioral Pharmacology Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Varenicline
Arm Description
Group given placebo.
Experimental group given varenicline dosing.
Outcomes
Primary Outcome Measures
Days to Relapse
Number of days following the programmed lapse exposure until relapse to smoking occurred
Secondary Outcome Measures
Full Information
NCT ID
NCT00944554
First Posted
July 21, 2009
Last Updated
July 28, 2017
Sponsor
Johns Hopkins University
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00944554
Brief Title
Relapse Prevention With Varenicline
Acronym
0815
Official Title
Relapse Prevention With Varenicline
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence, Smoking Cessation, Substance-Related Disorders
Keywords
Relapse, Smoking Cessation, Substance Abuse
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group given placebo.
Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Experimental group given varenicline dosing.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Varenicline (Chantix®)
Intervention Description
Varenicline given twice a day or five weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given twice a day or five weeks.
Primary Outcome Measure Information:
Title
Days to Relapse
Description
Number of days following the programmed lapse exposure until relapse to smoking occurred
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxine L Stitzer, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Relapse Prevention With Varenicline
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