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Contingency Management and Pharmacotherapy for Smoking Cessation (Donaghue)

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ClinicalTrials.gov Identifier: NCT00683280
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
UConn Health

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 (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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Behavioral: contingency management Other: Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contingency Management and Pharmacotherapy for Smoking Cessation
Study Start Date : May 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard of Care
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
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.
Other: Standard of Care
Twice weekly brief counseling based on public health service guidelines for quitting smoking.
Experimental: Standard of Care plus Contingency Management
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
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.
Other: Standard of Care
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.
Other: Standard of Care
Twice weekly brief counseling based on public health service guidelines for quitting smoking.



Primary Outcome Measures :
  1. Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report. [ Time Frame: weeks 5, 12 & 24 ]

Secondary Outcome Measures :
  1. Changes from baseline in ambulatory 24-hour systolic blood pressure. [ Time Frame: 6 and 24 weeks following the initiation of medication ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683280


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3944
Sponsors and Collaborators
UConn Health
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Sheila M Alessi, Ph.D. UConn Health

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00683280     History of Changes
Other Study ID Numbers: 08-035-3
DF 07-028 ( Other Grant/Funding Number: The Ethel Donaghue Center for Translating Research into Practice and Policy )
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UConn Health:
Contingency Management
Cigarette Smoking Cessation
varenicline

Additional relevant MeSH terms:
Varenicline
Carbon Monoxide
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antimetabolites
Gasotransmitters