Motivation and Nicotine Patch Treatment for Under-served Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01684995
First received: August 29, 2012
Last updated: September 12, 2012
Last verified: August 2012
  Purpose

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 Intervention
Smoking Cessation
Behavioral: Brief physician advice
Drug: nicotine patch
Behavioral: Individually Tailored Behavioral Skills training

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Motivation and Nicotine Patch Treatment for Under-served Smokers

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Study Start Date: December 1996
Study Completion Date: November 1999
Primary Completion Date: November 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684995

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
  More Information

No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01684995     History of Changes
Other Study ID Numbers: Quit_RIte_RI, R01DA010860
Study First Received: August 29, 2012
Last Updated: September 12, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014