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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00136812 |
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Date of registration:
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25/08/2005 |
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Primary sponsor: |
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Public title:
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Treating Tobacco Dependence in Inpatient Psychiatry - 1
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Scientific title:
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Treating Tobacco Dependence in Inpatient Psychiatry |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00136812 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Judith Prochaska |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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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. Other inclusion criteria include: 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco Use Cessation
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Tobacco Use Disorder
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Intervention(s)
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Behavioral: Tobacco Use Cessation
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Primary Outcome(s)
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7 day point prevalence of cigarette abstinence
[Time Frame: 1 week, 3 mo, 6 mo, 12 mo, and 18 mo post-baseline]
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Secondary ID(s)
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5K23DA018691-05
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K23-18691-1
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NIDA-18691-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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