Motivation and Nicotine Patch Treatment for Under-served Smokers

Smoking Cessation Clinical Trial

Official title:

Motivation and Nicotine Patch Treatment for Under-served Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684995
• Other study ID #: Quit_RIte_RI
• Secondary ID: R01DA010860
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: September 12, 2012
• Start date: December 1996
• Est. completion date: November 1999

Study information

• Verified date: August 2012
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 1999
• Est. primary completion date: November 1999
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,