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Motivation and Nicotine Patch Treatment for Under-served Smokers

Sponsor
The Miriam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01684995
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
1
Location
2
Arms
35
Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief physician advice
  • Drug: nicotine patch
  • Behavioral: Individually Tailored Behavioral Skills training
 N/A

Study Design

Study Type:
Interventional
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official Title:
Motivation and Nicotine Patch Treatment for Under-served Smokers
Study Start Date :
Dec 1, 1996
Actual Primary Completion Date :
Nov 1, 1999
Actual Study Completion Date :
Nov 1, 1999

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Minimal

Brief physician advice to quit smoking plus nicotine patch

Behavioral: Brief physician advice
Brief physician advice to quit smoking

Drug: nicotine patch
nicotine patch
Experimental: Tailored

Behavioral: Brief physician advice
Brief physician advice to quit smoking

Drug: nicotine patch
nicotine patch

Behavioral: Individually Tailored Behavioral Skills training
Individually tailored behavioral skills training for smoking cessation

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 18 years of age or older

    • Currently smoking at least 10 cigarettes/day for past 3 months

    • Speak English or Spanish

    • Have a telephone or live close to a relative or neighbor with a telephone

    • Agree to participate in the study and be available over the next 6 months.

    Exclusion Criteria:

    • Unable to use nicotine patch due to medical status

    • Active skin condition or history of skin allergy

    • Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment

    • Pregnant or nursing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Miriam Hospital Providence Rhode Island United States 02906

    Sponsors and Collaborators

    • The Miriam Hospital
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Miriam Hospital
    ClinicalTrials.gov Identifier:
    NCT01684995
    Other Study ID Numbers:
    • Quit_RIte_RI
    • R01DA010860
    First Posted:
    Sep 13, 2012
    Last Update Posted:
    Sep 13, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Nicotine

    Study Results

    No Results Posted as of Sep 13, 2012