Motivational Program for Smokers Enrolled in a Methadone... | NCT00278226

Studies
Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

NCT00278226

Sponsor

Butler Hospital

Status

Completed

Last Update Posted

Mar 24, 2010Estimated

Enrollment

398Actual

Phase

Not Applicable

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

smoking cessation intervention
educational intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01CA084392	U.S. NIH Grant/Contract		View source
RIH-0076-98

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Oct 2004Actual

Completion Date

Oct 2004Actual

First Submitted Date

Jan 16, 2006

First Submission Date that Met QC Criteria

Jan 16, 2006

First Posted Date

Jan 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2010

Last Update Posted Date

Mar 24, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.

PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.

Detailed Description

OBJECTIVES:

Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.

OUTLINE: Patients are assigned to 1 of 2 groups.

Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.

All patients will be offered a 2- to 3-month supply of nicotine patches.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

398Actual

Measure	Description	Time Frame
Nicotine Abstinence		6-months

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Must be currently enrolled in a methadone maintenance program
Smokes at least 10 cigarettes a day

PATIENT CHARACTERISTICS:

Not pregnant
No concurrent medical condition that precludes the use of nicotine patches

PRIOR CONCURRENT THERAPY:

No concurrent use of other nicotine replacement therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Stein, MD	Rhode Island Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital Comprehensive Cancer Center		Providence	Rhode Island	02903	United States

Intervention Browse Module

MeSH Terms

ID	Term
D018479	Early Intervention, Educational

Ancestor Terms

ID	Term
D002662	Child Health Services
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
smoking cessation intervention	Behavioral
educational intervention	Other