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Treating Tobacco Dependence in Inpatient Psychiatry - 1

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Judith Prochaska, Stanford University
ClinicalTrials.gov Identifier:
NCT00136812
First received: August 25, 2005
Last updated: April 23, 2016
Last verified: April 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Intervention: Behavioral: stage-tailored intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult smokers (N=224) were recruited between July 2006 and December 2008 from the adult inpatient psychiatry unit at the Langley Porter Psychiatric Institute (LPPI) located on the University of California, San Francisco (UCSF) medical school campus.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Usual care provided NRT during hospitalization with brief cessation advice.
Brief Treatment The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.

Participant Flow:   Overall Study
    Control     Brief Treatment  
STARTED     111     113  
COMPLETED     111     113  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Usual care provided NRT during hospitalization with brief cessation advice.
Brief Treatment The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
Total Total of all reporting groups

Baseline Measures
    Control     Brief Treatment     Total  
Number of Participants  
[units: participants]
  111     113     224  
Age  
[units: years]
Mean (Standard Deviation)
  39.9  (14.1)     39.9  (13.5)     39.9  (14)  
Gender, Customized  
[units: participants]
     
Female     71     63     134  
Male     36     48     84  
Other     4     2     6  



  Outcome Measures

1.  Primary:   7 Day Point Prevalence of Cigarette Abstinence   [ Time Frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Judith Prochaska, PhD, MPH; Associate Professor
Organization: Stanord University
phone: 650-724-3608
e-mail: JPro@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Judith Prochaska, Stanford University
ClinicalTrials.gov Identifier: NCT00136812     History of Changes
Other Study ID Numbers: NIDA-18691-1
5K23DA018691-05 ( US NIH Grant/Contract Award Number )
Study First Received: August 25, 2005
Results First Received: February 22, 2016
Last Updated: April 23, 2016
Health Authority: United States: Federal Government