Contingency Management and Pharmacotherapy for Smoking Cessation

NCT00683280 | Completed

• 2 other identifiers: 08-035-3DF 07-028
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

Contingency Management; Cigarette Smoking Cessation; varenicline

Outcome Measures

Primary Outcomes (1)

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

  weeks 5, 12 & 24

Secondary Outcomes (1)

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

  6 and 24 weeks following the initiation of medication

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Standard of Care plus Contingency Management

EXPERIMENTAL

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; Other: Standard of Care

Interventions

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 plus Contingency Management

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.

Standard of Care; Standard of Care plus Contingency Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3944, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sheila M Alessi, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (1)