Tobacco DependenceNCT00968513

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

A study testing Brief Intervention and Extended Treatment in people with Tobacco Dependence, run by Stanford University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tobacco Dependence
What is being tested?: Brief Intervention and Extended Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 956 participants
Where: 3 sitesUnited States
Study dates: Sep 2009to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants will be men and women 18 years of age and older, recruited from four acute inpatient psychiatry units at the Alta Bates Summit Medical Center - Herrick Campus, located in Berkeley, CA, one acute inpatient psychiatry unit at Langley Porter Psychiatric Institute, located in San Francisco, CA, and two acute inpatient psychiatry units at Stanford Hospital, located in Stanford, CA. Inclusion criteria are: smoking 5 or more cigarettes per day and at least 100 cigarettes in one's lifetime, no plan to relocate outside of the greater Bay Area in the next 18 months, and telephone access for scheduling follow-up assessments.

Who cannot join

Study exclusion criteria are: dementia or other brain injury precluding ability to participate; non-English speaking; complete homelessness; pregnancy or breastfeeding, and active ulcer disease (PUD). The relationship between nicotine and ulcers is a theoretical concern and our approach to now exclude patients with active ulcer disease is conservative. There is no data to show NRT causes/worsens ulcers. Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to consent to study participation. Threats of violence in particular are taken seriously, and patients will not be recruited if they may be a threat to study staff in the outpatient setting. At this point, non-English measurement and intervention materials are not available. Pregnant smokers will be referred out for more specialized behavioral treatments. Exclusionary criteria are purposefully minimal in order to maximize information about treating tobacco dependence in smokers in inpatient psychiatry. The study sample is anticipated to be diverse with respect to gender and ethnicity, educational and socioeconomic level, and psychiatric diagnoses.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Alta Bates Summit Medical Center
Berkeley, California, 94704
UCSF Langley Porter Psychiatric Institute
San Francisco, California, 94143
Stanford Hospital and Clinics
Stanford, California, 94304

Other trials in United States

About this study

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

Read the detailed description

Using a three group additive design, this randomized clinical trial (N=956) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are:

Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;
Brief Treatment (N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization;
Extended Treatment (N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

This study seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population; and (ii) if more extended and intensive treatment combining nicotine replacement therapy (NRT) with individualized, counselor-delivered motivational and manualized cessation-focused cognitive behavioral counseling (CBT) can outperform our current best practices. Ultimately, this research could lead to a model smoking cessation intervention for smokers with severe mental illness and, more generally, may provide a useful model for understanding the nature and complexity of intervening on comorbidities.

We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary specific aims will model the cost-effectiveness and budgetary impacts of the treatment conditions; examine moderators and mediators of treatment outcomes; and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time.

Conditions: Tobacco Dependence
Being tested: Brief Intervention, Extended Treatment, Usual Care
Keywords: Smoking Cessation, Inpatient Psychiatry, Stages of Change
Medical subject headings: Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief InterventionBehavioural
(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization
Extended TreatmentBehavioural
(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.
Usual CareBehavioural
(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Study groups in NCT00968513
Study group	Role	What they receive
Usual Care	Active comparator	(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization Receives: Behavioral: Usual Care
Brief Treatment	Experimental	(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization. Receives: Behavioral: Brief Intervention
Extended Treatment	Experimental	(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment. Receives: Behavioral: Extended Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months
Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months
Measured: 3, 6, 12, and 18 Month Follow-up
Commitment to Abstinence
Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit.
Measured: baseline, 3, 6, 12, and 18 months
Number of Participants With Quit Attempts Lasting 24 Hours or More
Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint.
Measured: 3, 6, 12, and 18 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jun 2015

First posted31 Aug 2009 (estimated)
Study startSep 2009
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Tobacco DependenceStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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
Model description: NRT
Masking: None (open label)
Enrolment: 956 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00968513
Sponsor's protocol ID: R01MH083684
Other IDs: R01MH083684, DAHBR A2-AID
Status last verified: May 2025
First submitted: 28 Aug 2009
Last updated: 11 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Prochaska JJ, Grana RA. E-cigarette use among smokers with serious mental illness. PLoS One. 2014 Nov 24;9(11):e113013. doi: 10.1371/journal.pone.0113013. eCollection 2014.
PubMed 25419703
Schuck RK, Dahl A, Hall SM, Delucchi K, Fromont SC, Hall SE, Bonas T, Prochaska JJ. Smokers with serious mental illness and requests for nicotine replacement therapy post-hospitalisation. Tob Control. 2016 Jan;25(1):27-32. doi: 10.1136/tobaccocontrol-2014-051712. Epub 2014 Sep 10.
PubMed 25209524
Prochaska JJ, Fromont SC, Delucchi K, Young-Wolff KC, Benowitz NL, Hall S, Bonas T, Hall SM. Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change. Health Psychol. 2014 Dec;33(12):1518-29. doi: 10.1037/a0035164. Epub 2014 Jan 27.
PubMed 24467257

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
ClinicalTrials.gov ID: NCT00968513
Acronym / sponsor ID: R01MH083684
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Inpatient Psychiatry, Stages of Change
Study type: Interventional
Recruitment status: Completed
Enrolment: 956 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Sep 2009
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 31 Aug 2009 (estimated)
Results: Posted 11 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

Detailed description

Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;
Brief Treatment (N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization;
Extended Treatment (N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: NRT

Arm	Type	Receives
Usual Care	Active comparator	Behavioral: Usual Care(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
Brief Treatment	Experimental	Behavioral: Brief Intervention(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization.
Extended Treatment	Experimental	Behavioral: Extended Treatment(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants will be men and women 18 years of age and older, recruited from four acute inpatient psychiatry units at the Alta Bates Summit Medical Center - Herrick Campus, located in Berkeley, CA, one acute inpatient psychiatry unit at Langley Porter Psychiatric Institute, located in San Francisco, CA, and two acute inpatient psychiatry units at Stanford Hospital, located in Stanford, CA. Inclusion criteria are: smoking 5 or more cigarettes per day and at least 100 cigarettes in one's lifetime, no plan to relocate outside of the greater Bay Area in the next 18 months, and telephone access for scheduling follow-up assessments.

Key exclusion criteria (1 listed)

Study exclusion criteria are: dementia or other brain injury precluding ability to participate; non-English speaking; complete homelessness; pregnancy or breastfeeding, and active ulcer disease (PUD). The relationship between nicotine and ulcers is a theoretical concern and our approach to now exclude patients with active ulcer disease is conservative. There is no data to show NRT causes/worsens ulcers. Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to consent to study participation. Threats of violence in particular are taken seriously, and patients will not be recruited if they may be a threat to study staff in the outpatient setting. At this point, non-English measurement and intervention materials are not available. Pregnant smokers will be referred out for more specialized behavioral treatments. Exclusionary criteria are purposefully minimal in order to maximize information about treating tobacco dependence in smokers in inpatient psychiatry. The study sample is anticipated to be diverse with respect to gender and ethnicity, educational and socioeconomic level, and psychiatric diagnoses.

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
Brief Intervention(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization	Behavioural	Brief Treatment
Extended Treatment(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.	Behavioural	Extended Treatment
Usual Care(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Behavioural	Usual Care

Primary outcome

Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months
Time frame: 3, 6, 12, and 18 Month Follow-up
Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months
Commitment to Abstinence
Time frame: baseline, 3, 6, 12, and 18 months
Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit.
Number of Participants With Quit Attempts Lasting 24 Hours or More
Time frame: 3, 6, 12, and 18 months follow-up
Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint.

Results and safety

Results posted to the registry on 11 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	132	128
Brief Treatment	416	406
Extended Treatment	408	393

Primary outcome: Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months

Time frame: 3, 6, 12, and 18 Month Follow-up. Count of participants. Unit: Participants

Measure	Usual Care n = 132	Brief Treatment n = 416	Extended Treatment n = 408
3 month	13	70	63
6 month	15	75	78
12 month	21	78	74
18 month	17	80	82

Primary outcome: Commitment to Abstinence

Time frame: baseline, 3, 6, 12, and 18 months. Mean (Full Range). Unit: score on a scale

Measure	Usual Care n = 132	Brief Treatment n = 416	Extended Treatment n = 408
Baseline	5.83 (1 to 10)	6.20 (1 to 10)	5.85 (1 to 10)
3 month	6.27 (1 to 10)	7.44 (1 to 10)	7.09 (1 to 10)
6 month	6.65 (1 to 10)	7.22 (1 to 10)	7.21 (1 to 10)
12 month	7.06 (1 to 10)	7.44 (1 to 10)	7.33 (1 to 10)
18 month	7.05 (1 to 10)	7.47 (1 to 10)	7.37 (1 to 10)

Population analysed: Missing values at each timepoint per group were excluded from analyses.

Primary outcome: Number of Participants With Quit Attempts Lasting 24 Hours or More

Time frame: 3, 6, 12, and 18 months follow-up. Number. Unit: participants

Measure	Usual Care n = 132	Brief Treatment n = 416	Extended Treatment n = 408
3 month	42	181	162
6 month	40	169	149
12 month	47	156	170
18 month	47	183	165

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	105 of 132 (79.5%)	17 of 132 (12.9%)	Not reported
Brief Treatment	308 of 416 (74%)	120 of 416 (28.8%)	Not reported
Extended Treatment	310 of 408 (76%)	126 of 408 (30.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25419703Prochaska JJ, Grana RA. E-cigarette use among smokers with serious mental illness. PLoS One. 2014 Nov 24;9(11):e113013. doi: 10.1371/journal.pone.0113013. eCollection 2014.
Derived from this study: PubMed 25209524Schuck RK, Dahl A, Hall SM, Delucchi K, Fromont SC, Hall SE, Bonas T, Prochaska JJ. Smokers with serious mental illness and requests for nicotine replacement therapy post-hospitalisation. Tob Control. 2016 Jan;25(1):27-32. doi: 10.1136/tobaccocontrol-2014-051712. Epub 2014 Sep 10.
Derived from this study: PubMed 24467257Prochaska JJ, Fromont SC, Delucchi K, Young-Wolff KC, Benowitz NL, Hall S, Bonas T, Hall SM. Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change. Health Psychol. 2014 Dec;33(12):1518-29. doi: 10.1037/a0035164. Epub 2014 Jan 27.
Individual participant dataSharing planned: No

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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.

Judith J. Prochaska, PhD, MPH principal investigator

Stanford University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Intervention and Extended Treatment in people with Tobacco Dependence, run by Stanford University at 3 sites 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 1 inclusion and 1 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months (time frame: 3, 6, 12, and 18 Month Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00968513, which also lists 3 linked publications.

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 11 Jun 2025.