Contingency Management and Pharmacotherapy for Smoking Cessation

NCT ID: NCT00683280

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-08-31

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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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.

Standard of Care

Intervention Type: OTHER

Twice weekly brief counseling based on public health service guidelines for quitting smoking.

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.

Group Type: EXPERIMENTAL

contingency management

Intervention Type: 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

Intervention Type: 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.

Standard of Care

Intervention Type: OTHER

Twice weekly brief counseling based on public health service guidelines for quitting smoking.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Standard of Care

Twice weekly brief counseling based on public health service guidelines for quitting smoking.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Donaghue Medical Research Foundation

OTHER

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila M Alessi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

DF 07-028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

08-035-3

Identifier Type: -

Identifier Source: org_study_id