Comparing Smoking Treatment Programs for Lighter Smokers - 1

NCT00086411 | Completed Phase 2 Results DMC

• 2 other identifiers: NIDA-15365-1R01DA015365
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder

Keywords

light smokers, smoking cessation treatment programs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.

  52 weeks

Study Arms (4)

1: Bup+MM

EXPERIMENTAL

bupropion and MM counseling with placebo patch

Drug: bupropion; Behavioral: Medication Management; Drug: placebo patch

2 Bup+Mayo

EXPERIMENTAL

bupropion and Mayo counseling with placebo patch.

Drug: bupropion; Behavioral: Mayo Counseling; Drug: placebo patch

3 Patch+MM

PLACEBO COMPARATOR

patch and MM counseling with placebo pills

Drug: nicotine transdermal system; Behavioral: Medication Management; Drug: placebo bupropion

4 Patch+Mayo

EXPERIMENTAL

patch and Mayo counseling with placebo pills

Drug: nicotine transdermal system; Behavioral: Mayo Counseling; Drug: placebo bupropion

Interventions

nicotine transdermal system DRUG

starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.

Also known as: Nicoderm

3 Patch+MM; 4 Patch+Mayo

bupropion DRUG

150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks

Also known as: Zyban

1: Bup+MM; 2 Bup+Mayo

Medication Management BEHAVIORAL

Brief manual based therapy; four 15 minute session over 10 weeks.

1: Bup+MM; 3 Patch+MM

Mayo Counseling BEHAVIORAL

Manual based therapy; Weekly 30 minute sessions for 10 weeks

2 Bup+Mayo; 4 Patch+Mayo

placebo patch DRUG

placebo patch containing no nicotine

1: Bup+MM; 2 Bup+Mayo

placebo bupropion DRUG

placebo pills

3 Patch+MM; 4 Patch+Mayo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Please contact site for more information

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.jsat.2007.08.009. Epub 2007 Oct 10.

  PMID: 17931823 BACKGROUND

• 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 31.

  PMID: 19339135 RESULT

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine; Bupropion; Medication Therapy Management

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones; Organic Chemicals; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

Missing data from some early terminations from treatment (i.e., 2 or less visits) may reflect dissatisfaction with counseling assignment or medication effects.

Results Point of Contact

• Title: Peter Gariti, Ph.D.
• Organization: University of Pennsylvania

gar1iti@mail.med.upenn.edu

215-222-3200

Study Officials

• Peter W Gariti, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2004
• First Posted: July 7, 2004
• Study Start: September 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2009
• Last Updated: August 6, 2019
• Results First Posted: March 11, 2014

Record last verified: 2019-07

Locations

US (1)