NCT01684995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1996

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
Last Updated

September 13, 2012

Status Verified

August 1, 2012

Enrollment Period

2.9 years

First QC Date

August 29, 2012

Last Update Submit

September 12, 2012

Conditions

Study Arms (2)

Minimal

ACTIVE COMPARATOR

Brief physician advice to quit smoking plus nicotine patch

Behavioral: Brief physician adviceDrug: nicotine patch

Tailored

EXPERIMENTAL
Behavioral: Brief physician adviceDrug: nicotine patchBehavioral: Individually Tailored Behavioral Skills training

Interventions

Brief physician advice to quit smoking

MinimalTailored

nicotine patch

MinimalTailored

Individually tailored behavioral skills training for smoking cessation

Tailored

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Bock B, Lopes CE, van den Berg JJ, Roberts MB, Stein LA, Martin RA, Martin SA, Clarke JG. Social support and smoking abstinence among incarcerated adults in the United States: a longitudinal study. BMC Public Health. 2013 Sep 17;13:859. doi: 10.1186/1471-2458-13-859.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 13, 2012

Study Start

December 1, 1996

Primary Completion

November 1, 1999

Study Completion

November 1, 1999

Last Updated

September 13, 2012

Record last verified: 2012-08

Locations