Contingency Management and Pharmacotherapy for Smoking Cessation - Full Text View

Sponsors and Collaborators:	University of Connecticut Health Center Donaghue Medical Research Foundation
Information provided by:	University of Connecticut
ClinicalTrials.gov Identifier:	NCT00683280

Purpose

In total, 70 smokers will be randomized to: 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	Intervention	Phase
Cigarette Smoking	Behavioral: contingency management Drug: varenicline (smoking cessation medication) Behavioral: Brief counseling for quitting smoking	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Carbon monoxide Cotinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Contingency Management and Pharmacotherapy for Smoking Cessation

Further study details as provided by University of Connecticut:

Primary Outcome Measures:

Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report. [ Time Frame: weeks 5, 12 & 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes from baseline in ambulatory 24-hour systolic blood pressure. [ Time Frame: 6 and 24 weeks following the initiation of medication ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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).	Drug: 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. Behavioral: Brief counseling for quitting smoking Twice weekly brief counseling based on public health service guidelines for quitting smoking.
B: 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 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. Drug: 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. Behavioral: Brief counseling for quitting smoking Twice weekly brief counseling based on public health service guidelines for quitting smoking.

Arms

Assigned Interventions

A: 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).

Drug: 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.

Behavioral: Brief counseling for quitting smoking

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

B: 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

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.

Drug: 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.

Behavioral: Brief counseling for quitting smoking

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683280

Contacts

Contact: Ellen M Ciesielski, B.A.

860-679-4556

ciesielski@psychiatry.uchc.edu

Locations

United States, Connecticut
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030-3944
Principal Investigator: Sheila M Alessi, Ph.D.

Sponsors and Collaborators

University of Connecticut Health Center

Donaghue Medical Research Foundation

Investigators

Principal Investigator:

Sheila M Alessi, Ph.D.

University of Connecticut Health Center

More Information

Responsible Party:	University of Connecticut Health Center ( Sheila Alessi, Ph.D. )
Study ID Numbers:	08-035-3, DF 07-028
Study First Received:	May 14, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00683280
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut:

Contingency Management
Cigarette Smoking Cessation
varenicline

Study placed in the following topic categories:

Smoking
Carbon Monoxide

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 16, 2009