Contingency Management and Pharmacotherapy for Smoking Cessation (Donaghue)

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: Standard of Care; Other: Standard of Care; Behavioral: contingency management

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030-3944
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Donaghue Medical Research Foundation
• Investigators: Principal Investigator: Sheila M Alessi, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (Estimate): May 23, 2008

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: varenicline; Contingency Management; Cigarette Smoking Cessation
• 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No