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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: |
NCT01372254 |
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Date of registration:
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10/06/2011 |
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Primary sponsor: |
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Public title:
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Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
BA-DAS |
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Scientific title:
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Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01372254 |
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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: Single Blind (Subject), 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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Laura MacPherson, PhD |
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Address:
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Telephone:
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Email:
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lmacpherson@psyc.umd.edu |
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Affiliation:
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Name:
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Laura MacPherson, PhD |
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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 Maryland College Park, Center for Addictions, Personality, and Emotions Research (CAPER) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- between 18 and 65 years of age
- regular smoker for at least one year
- currently smoking an average = 10 cigarettes (also cigarellos, bidis, or Black and
Milds included) per day
- report motivation to quit smoking in the next month
- report elevated depressive symptoms
Exclusion Criteria:
- physical concerns contraindicating the nicotine patch
- limited mental competency and/or the inability to give informed, voluntary, written
consent to participate
- current use of pharmacotherapy for smoking cessation not provided by the researchers
during the quit attempt
- use of psychotropic medication for < 3 months
- primary use of other tobacco products (specifically: chewing tobacco, cigars, and
pipes)
- psychotic symptoms
- current pregnancy or plans to become pregnant within the following three months
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cigarette Smoking
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Drug Use
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Intervention(s)
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Behavioral: BAD-AS
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Behavioral: Standard Treatment
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Drug: Transdermal Nicotine Patch
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Primary Outcome(s)
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Smoking abstinence based on expired carbon monoxide tests, saliva cotinine tests, and self-report
[Time Frame: 26 weeks post quit date]
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Secondary Outcome(s)
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Changes in Mood and Depressive Symptoms
[Time Frame: Baseline to 26 weeks post quit date]
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Secondary ID(s)
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RSGT1101101CPPD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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