NCT01325727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

March 28, 2011

Last Update Submit

November 13, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • % quit smoking

    4 weeks

Study Arms (2)

Brief computerized feedback

EXPERIMENTAL

Brief computerized feedback

Other: Brief computerized feedback

Resources only

ACTIVE COMPARATOR
Other: Resources only (control)

Interventions

Brief computerized feedback

Brief computerized feedback

Participants randomized to the control group will discuss the option of quitting smoking, along with an information sheet, highlighting resources available to assist participants with smoking cessation, such as the Virginia Quitline (1-800 QUIT NOW) and nicotine replacement therapy.

Resources only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Addiction and Recovery Alliance Center

Midlothian, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alison Breland, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations