- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136812
Treating Tobacco Dependence in Inpatient Psychiatry - 1
Treating Tobacco Dependence in Inpatient Psychiatry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- San Francisco General Hospital
-
San Francisco, California, United States, 94143
- Langley Porter Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Men and women over 18 years of age hospitalized on an inpatient psychiatric unit who report smoking at least 5 cigarettes per day; smoking at least 100 cigarettes in one's lifetime, residing in the San Francisco Bay Area with no plan to relocate outside of the area in the next 18 months, and access to a telephone for scheduling follow up assessments.
Exclusion Criteria: Dementia or other brain injury precluding ability to participate; non-English speaking; severe agitation, psychosis, or hostility; and medical contraindications to nicotine replacement therapy (NRT). Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms. Medical contraindications are: myocardial infarction in the preceding 3 months, unstable angina pectoris, liver or kidney disease, current pregnancy or breast feeding, allergies to adhesives, or other medical conditions that the medical team deems incompatible with NRT use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: enhanced usual care control
NRT during hospitalization with brief advice to stay quit once discharged
|
|
Experimental: stage-tailored intervention
NRT during hospitalization with brief advice to stay quit once discharged plus a computer-delivered stage-tailored smoking cessation intervention with manual and counseling plus 10-weeks of nicotine patch available post-hospitalization
|
This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization.
Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
7 Day Point Prevalence of Cigarette Abstinence
Time Frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline
|
3 mo, 6 mo, 12 mo, and 18 mo post-baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith Prochaska, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-18691-1
- 5K23DA018691-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Use Disorder
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco DependenceUnited States
-
Harvard School of Public Health (HSPH)Beacon Communities; The Community BuildersEnrolling by invitationTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Second Hand Tobacco SmokeUnited States
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramCompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
New York State Psychiatric InstituteTerminatedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Nicotine Dependence | Cigarette Smoking | Tobacco Dependence | Nicotine Use Disorder | Smoking, CigaretteUnited States
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Schizoaffective Disorder | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use CessationUnited States
-
University of PennsylvaniaFood and Drug Administration (FDA)Completed
-
University of Kansas Medical CenterCompletedTobacco Use Disorder/Cigarette SmokingUnited States
-
Ottawa Hospital Research InstituteCompletedTobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence
Clinical Trials on stage-tailored intervention
-
University Medicine GreifswaldGerman Research FoundationCompleted
-
Narrows Institute for Biomedical ResearchCompletedStroke | Transient Ischemic AttackUnited States
-
University of Rhode IslandCompleted
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Massachusetts General Hospital; Fox Chase Cancer... and other collaboratorsCompletedCancer | Colorectal | Intervention | ScreeningUnited States
-
University of California, San DiegoNational Institute of Nursing Research (NINR)CompletedInactivityUnited States
-
Duke UniversityNational Cancer Institute (NCI)Completed
-
Rabin Medical CenterAcademic College of Tel Aviv-Jaffa; Israel Cancer AssociationUnknownOvarian Cancer | Cancer of Cervix | Cancer of EndometriumIsrael
-
University of Colorado, DenverWashington State University; Missouri Breaks Industries Research, Inc.RecruitingAlzheimer DiseaseUnited States
-
Nova Southeastern UniversityEmory UniversityCompletedDepression | Pain | Sleep Wake Disorders | Fatigue | Chronic DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States