Contingency Management and Pharmacotherapy for Smoking Cessation



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/17/2018
Start Date:May 2008
End Date:August 2010

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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 (CM) (a behavioral procedure with rewards for target behaviors, like
smoking abstinence). Patients in both conditions will receive varenicline for 12 weeks with
standard smoking cessation therapy and regular breath and urine sample monitoring for
smoking. Patients assigned to CM will earn chances to win prizes for each breath sample that
tests negative for smoking, and urine samples that test negative for smoking will result in
even greater chances for prizes. More CM patients are expected to achieve and maintain
abstinence than patients receiving varenicline alone.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
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