Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
NCT ID: NCT01730846
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2013-02-28
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Doxazosin 4mg/day
doxazosin 4mg/day
Doxazosin 4mg/day
4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Placebo
placebo control
Placebo
Placebo
Doxazosin 8mg/day
doxazosin 8mg/day
Doxazosin 8mg/day
8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Interventions
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Doxazosin 4mg/day
4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Placebo
Placebo
Doxazosin 8mg/day
8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read and write English
* Smoker
* Motivated to Quit Smoking
Exclusion Criteria
* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* Positive test results at intake appointment on urine drug screens for illicit drugs
* Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
* Participants who have donated blood within the past 6 weeks
* Individuals who are currently taking other medications prescribed for smoking cessation
* Specific exclusions for administration of doxazosin or any alpha blocker
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Sherry McKee
Associate Professor of Psychiatry
Principal Investigators
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Sherry A McKee, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1111009293
Identifier Type: -
Identifier Source: org_study_id
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