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OpenTrials
Completed

NCT Number: NCT00683280

Contingency Management and Pharmacotherapy for Smoking Cessation

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.

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Key information

Conditions

Cigarette Smoking Behavior Health Behavior Smoking Tobacco Smoking Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-3944, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

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.

Standard of care

Other

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.

Primary outcomes

  1. Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report.

    Time frame: weeks 5, 12 & 24

Secondary outcomes

  1. Changes from baseline in ambulatory 24-hour systolic blood pressure.

    Time frame: 6 and 24 weeks following the initiation of medication

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Donaghue Medical Research Foundation

Registry information

Acronym: Donaghue

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 23, 2008
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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