Motivation and Nicotine Patch Treatment for Under-served Smokers

NCT ID: NCT01684995

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

1999-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Minimal

Brief physician advice to quit smoking plus nicotine patch

Group Type ACTIVE_COMPARATOR

Brief physician advice

Intervention Type BEHAVIORAL

Brief physician advice to quit smoking

nicotine patch

Intervention Type DRUG

nicotine patch

Tailored

Group Type EXPERIMENTAL

Brief physician advice

Intervention Type BEHAVIORAL

Brief physician advice to quit smoking

nicotine patch

Intervention Type DRUG

nicotine patch

Individually Tailored Behavioral Skills training

Intervention Type BEHAVIORAL

Individually tailored behavioral skills training for smoking cessation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief physician advice

Brief physician advice to quit smoking

Intervention Type BEHAVIORAL

nicotine patch

nicotine patch

Intervention Type DRUG

Individually Tailored Behavioral Skills training

Individually tailored behavioral skills training for smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24044880 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA010860

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Quit_RIte_RI

Identifier Type: -

Identifier Source: org_study_id