Status:
COMPLETED
Contingency Management and Pharmacotherapy for Smoking Cessation
Lead Sponsor:
UConn Health
Collaborating Sponsors:
Donaghue Medical Research Foundation
Conditions:
Cigarette Smoking
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In total, 70 smokers will be randomized to: standard of care smoking cessation medication varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus contingency management (C...
Eligibility Criteria
Inclusion
- smoke \>10 cigarettes/day, with no abstinent period exceeding 3 months in past year
- expired CO of \>8 ppm
- self-reported desire to stop smoking
- \>18 years of age
- resting systolic BP\<160 mmHg and diastolic BP\<100 mmHg and otherwise in good health
- if on antihypertensive medication, have not changed medications in the past month and do not intend to change in next 3 months
- English speaking
Exclusion
- receipt of smoking cessation treatment (behavioral or pharmacological) in past month
- serious or unstable medical disease in past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
- evidence or history of allergic reactions contraindicating varenicline or clinically significant laboratory or electrocardiographic (ECG) abnormalities
- breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
- arm circumference of \>42 cm
- serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
- use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
- ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
- in recovery for pathological gambling, due to potential similarity with prize CM, although no increases in gambling have been noted
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00683280
Start Date
May 1 2008
End Date
August 1 2010
Last Update
January 16 2018
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3944