Brief Computerized Feedback for Smokers in Recovery | NCT01325727

Studies
Brief Computerized Feedback for Smokers in Recovery

NCT01325727

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Nov 15, 2012Estimated

Enrollment

151Actual

Phase

Not Applicable

Conditions

Smoking

Interventions

Brief computerized feedback
Resources only (control)

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

Status Module

Record Verification Date

Nov 2012

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

Mar 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Mar 29, 2011

First Posted Date

Mar 30, 2011Estimated

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

Nov 13, 2012

Last Update Posted Date

Nov 15, 2012Estimated

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

The purpose of this research study is to find out more about smokers in recovery from addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior feedback session. The hypothesis is that a brief computerized smoking behavior feedback session will motivate more smokers to quit smoking than a control condition.

Detailed Description

Not provided

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

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brief computerized feedback	Experimental	Brief computerized feedback	Other: Brief computerized feedback
Resources only	Active Comparator		Other: Resources only (control)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brief computerized feedback	Other	Brief computerized feedback	Brief computerized feedback

Measure	Description	Time Frame
% quit smoking		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be 18 years of age or older
Be in recovery from addiction to alcohol and/or drugs (self-defined)
Have smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
Have smoked at least 100 cigarettes (lifetime)
Have an expired air carbon monoxide (CO) level of > 6 ppm (verifies current smoking)
Be cognitively able to understand the proposed research design (screening followed by random assignment to one of the two conditions, if appropriate)

To be eligible to receive NRT (if chosen by the participant), participants must:

Not be pregnant, breastfeeding, or plan to become pregnant in the next year
Not have experienced a myocardial infarction (heart attack) or have been hospitalized for a heart-related problem in the last 2 weeks

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alison Breland, PhD	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Substance Abuse Addiction and Recovery Alliance Center		Midlothian	Virginia	23225	United States