Smoking CessationINSPIRENCT00714896
Interventions for Smoking Among Persons in Recovery
A study testing Stepped-Care in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Stepped-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Central Diablo (Wlanut Creek/ Martinez)
Walnut Creek, California, 94596
About this study
Official title: A Stepped-Care Intervention for Current and Former Smokers in Outpatient Chemical Dependency Treatment
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.
Read the detailed 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:
- 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
- Pre-test the efficacy of the stepped-care smoking cessation intervention.
- Examine the feasibility of implementing the stepped-care smoking cessation intervention.
- Examine the impact of the smoking intervention on drug and alcohol use outcomes at 6-month post initiation of smoking cessation treatment.
- Conditions
- Smoking Cessation
- Being tested
- Stepped-Care, Control
- Keywords
- smoking cessation, nicotine dependence, stage-based intervention, nicotine replacement medications, counseling, substance abuse treatment
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped-CareBehavioural
- 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
ControlBehavioural
Referral list to smoking cessation classes at Kaiser and the California Smokers Helpline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Assessment only + referral list to State quitline and smoking cessation education classes at Kaiser Receives: 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. Receives: Behavioral: Stepped-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO verified self-report 7-day smoking abstinence prior to assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Janice Tsoh, Ph.D., University of California, San Francisco
- Investigators
- Janice Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714896
- Sponsor's protocol ID
- P50DA009253-14-DevStudy2
- Other IDs
- H10315-28247-03, P50DA009253-14
- Acronym
- INSPIRE
- Status last verified
- May 2013
- First submitted
- 9 Jul 2008
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped-Care Intervention for Current and Former Smokers in Outpatient Chemical Dependency Treatment
- ClinicalTrials.gov ID
- NCT00714896
- Acronym / sponsor ID
- INSPIRE / P50DA009253-14-DevStudy2
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, nicotine dependence, stage-based intervention, nicotine replacement medications, counseling, substance abuse treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- Pre-test the efficacy of the stepped-care smoking cessation intervention.
- Examine the feasibility of implementing the stepped-care smoking cessation intervention.
- Examine the impact of the smoking intervention on drug and alcohol use outcomes at 6-month post initiation of smoking cessation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: ControlAssessment only + referral list to State quitline and smoking cessation education classes at Kaiser |
| 2 | Experimental | Behavioral: Stepped-CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | 2 |
| ControlReferral list to smoking cessation classes at Kaiser and the California Smokers Helpline | Behavioural | 1 |
Primary outcome
CO verified self-report 7-day smoking abstinence prior to assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Tsoh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped-Care in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CO verified self-report 7-day smoking abstinence prior to assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.