NCT00714896

Brief Summary

Examine the efficacy of a stepped-care smoking cessation intervention for current and former smokers in chemical dependency treatment programs. We hypothesize that those who received the stepped-care intervention will be more likely to report smoking abstinence and drug or alcohol abstinence at 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

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

April 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

July 9, 2008

Last Update Submit

May 25, 2013

Conditions

Smoking Cessation

Keywords

smoking cessationnicotine dependencestage-based interventionnicotine replacement medicationscounselingsubstance abuse treatment

Outcome Measures

Primary Outcomes (1)

  • CO verified self-report 7-day smoking abstinence prior to assessment

    6 months

Study Arms (2)

1

OTHER

Assessment only + referral list to State quitline and smoking cessation education classes at Kaiser

Behavioral: Control

2

EXPERIMENTAL

Participants will receive self-help information handouts, expert system intervention that includes a stage-based manual and individualized written feedback reports plus in-person brief stage-appropriate counseling at baseline and 3-month assessment. Current smokers who indicate desire to quit smoking or former smokers who indicate high cravings for cigarettes will be offered nicotine replacement medications. Participants will receive three telephone counseling sessions delivered between baseline and 3 month at weeks 2, 4 and 8. As-needed telephone check-calls will be provided to participants on and 2 days after quit date, or to participants who have quit smoking and anticipate high risk situations.

Behavioral: Stepped-Care

Interventions

Stepped-CareBEHAVIORAL

* stage-based expert system written intervention at baseline and 3 months * in-person stage appropriate counseling at baseline and 3 months * telephone counseling sessions at weeks 2,4 and 8, * as-needed brief check-in calls on or 2 days after quit date for those who have set a quit date; and/or check-in calls on days with anticipated high risk situations for former smokers or those who have quit smoking during the study * optional NRT nicotine replacement therapy in the forms of patch, gum or lozenge for current smokers who are ready to quit smoking and/or for former smokers who report significantly strong smoking urges

2
ControlBEHAVIORAL

Referral list to smoking cessation classes at Kaiser and the California Smokers Helpline

1

Eligibility Criteria

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

You may qualify if:

  • men and women
  • over the age of 18
  • currently enrolled in outpatient treatment program for drug and/or alcohol use and have received minimally 30 days of continuous treatment for drug and/alcohol in any outpatient treatment program(s) for drug and/or alcohol use for at least one month
  • have regularly smoked cigarettes for at least one year in their lifetime
  • have smoked within the past 5 years

You may not qualify if:

  • clients with a life-threatening disease
  • currently at imminent risk of committing suicide, or currently pregnant
  • currently in treatment for nicotine dependence elsewhere
  • cannot be reached by telephone (unable to provide a phone number where the participant can be reached directly
  • non-English speakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Central Diablo (Wlanut Creek/ Martinez)

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Janice Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Study Completion

August 1, 2009

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(1)