Comparing Smoking Treatment Programs for Lighter Smokers - 1

Tobacco Use Disorder Clinical Trial

Official title:

Comparing Smoking Treatment Programs for Lighter Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086411
• Other study ID #: NIDA-15365-1
• Secondary ID: R01DA015365
• Status: Completed
• Phase: Phase 2
• Start date: September 2003
• Est. completion date: June 2009

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Description:

The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Light smokers (6-15 cigarettes per day

Inclusion Criteria:

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria:

Please contact site for more information

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• nicotine transdermal system
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
• bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks

Behavioral:
• Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
• Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks

Drug:
• placebo patch
placebo patch containing no nicotine
• placebo bupropion
placebo pills

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gariti P, Levin S, Whittingham T, Barou D, Kampman KM, Lynch K, Halbert CH, Alterman A. Why do those who request smoking treatment fail to attend the first appointment? J Subst Abuse Treat. 2008 Jul;35(1):62-7. Epub 2007 Oct 10. — View Citation

Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. J Subst Abuse Treat. 2009 Oct;37(3):247-55. doi: 10.1016/j.jsat.2009.01.006. Epub 2009 Mar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Treatment Sessions Attended	Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.; A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.; Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.	52 weeks
Secondary	Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.		52 weeks