Gradual vs. Abrupt Cessation Treatment for Smoking

This study has been completed.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00297492

Purpose

This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.

Condition	Intervention	Phase
Smoking Cessation	Drug: Commit Nicotine Lozenges Behavioral: Proactive phone counseling	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Gradual vs. Abrupt Cessation Treatment for Smoking

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Prolonged abstinence through 6 months. [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	January 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

interested in quitting gradually, at least 18 years old, daily smoker, smokes at least 15 cigarettes per day (CPD), no change greater than 20% in CPD in the last month, interested in quitting in next 30 days, must agree to not use non-cigarette tobacco during study, no use of smoking cessation medication in last month, have phone with voice mail, willing to use nicotine lozenge, no other person in household in study fluent/literate in English

Exclusion Criteria:

women who are pregnant or breastfeeding, currently using medication for depression or asthma, heart disease requiring medication, heart attack in last month, irregular heartbeat, high blood pressure not controlled by medication, stomach ulcers, diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297492

Locations

United States, Vermont
University of Vermont Human Behavioral Pharmacology Lab
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

John Hughes, MD

University of Vermont

More Information

Responsible Party:	University of Vermont ( John Hughes, MD )
Study ID Numbers:	R01 DA11557-07
Study First Received:	February 24, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00297492
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 15, 2009