Interventions for Smoking Among Persons in Recovery

Smoking Cessation Clinical Trial

— INSPIRE  

Official title:

A Stepped-Care Intervention for Current and Former Smokers in Outpatient Chemical Dependency Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714896
• Other study ID #: P50DA009253-14-DevStudy2
• Secondary ID: H10315-28247-03P
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: May 25, 2013
• Start date: April 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of the study is to document and systematically investigate the use of smoking cessation strategies targeting substance abuse outpatient smokers at various level of readiness to quit smoking. Little is known regarding the best practices in treating tobacco use among clients in drug abuse treatment and very few drug abuse treatment programs currently offer smoking cessation services. The purpose of this developmental study is to develop and pre-test a stepped-care smoking cessation intervention in an outpatient drug abuse treatment program at a managed care setting that targets both current and former smokers. The stepped-care intervention consists of various components that aim at matching the treatment needs of smokers across the whole spectrum of smoking status and readiness to quit smoking. The following specific aims will be pursued:

1. Develop a stepped-care smoking cessation intervention targeting both current and former smokers who are admitted to an outpatient drug abuse treatment program. Special attention will be paid to former smokers, as intervention techniques for them are not well developed. Also, intervention content will be modified from that used in smoking interventions with the general population to content that is targeted at smokers who are in drug abuse treatment

2. Pre-test the efficacy of the stepped-care smoking cessation intervention.

3. Examine the feasibility of implementing the stepped-care smoking cessation intervention.

4. Examine the impact of the smoking intervention on drug and alcohol use outcomes at 6-month post initiation of smoking cessation treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Stepped-Care
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
• Control
Referral list to smoking cessation classes at Kaiser and the California Smokers Helpline

Locations

Country	Name	City	State
United States	Kaiser Permanente Central Diablo (Wlanut Creek/ Martinez)	Walnut Creek	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Permanente, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO verified self-report 7-day smoking abstinence prior to assessment		6 months	No