Contingency Management and Pharmacotherapy for Smoking Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Contingency Management and Pharmacotherapy for Smoking Cessation

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: contingency management
* Other: Standard of Care
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Medication (varenicline) for 12 weeks (Day 1 through 84) and brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35). | Other: Standard of Care<br>* varenicline (smoking cessation medication) 0.5mg po daily Days 1-3, 0.5mg po twice daily Days 4-7, 1.0 mg po twice daily Days 8-84.<br>Other: Standard of Care<br>* Twice weekly brief counseling based on public health service guidelines for quitting smoking.<br>|
| Experimental: Standard of Care plus Contingency Management<br>Medication (varenicline) for 12 weeks (Day 1 through 84), brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35), plus prize-based contingency management for carbon monoxide samples and urinary cotinine samples that meet smoking abstinence criteria. | Behavioral: contingency management<br>* Prize-based contingency management, with the opportunity to earn prizes for expired carbon monoxide levels reading 6ppm or less and urinary cotinine levels reading 30ng/ml or less for 4 weeks.<br>Other: Standard of Care<br>* varenicline (smoking cessation medication) 0.5mg po daily Days 1-3, 0.5mg po twice daily Days 4-7, 1.0 mg po twice daily Days 8-84.<br>Other: Standard of Care<br>* Twice weekly brief counseling based on public health service guidelines for quitting smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report. |  | weeks 5, 12 & 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in ambulatory 24-hour systolic blood pressure. |  | 6 and 24 weeks following the initiation of medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contingency Management, Cigarette Smoking Cessation, varenicline