Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking
Intervention: Doxazosin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s): Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
Summary
The purpose of this study is to examine whether doxazosin will attenuate the ability of
stress to precipitate smoking lapse behavior in treatment seeking daily smokers.
Participants will participate in a smoking cessation attempt after the laboratory sessions.
Clinical Details
Official title: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Latency (min) to initiate ad-lib smoking session
Secondary outcome: Number of cigarettes smoked during ad-lib sessionDays to first lapse during quit attempt End of treatment 7-day point prevalence
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ages 18-60
- Able to read and write English
- Smoker
- Motivated to Quit Smoking
Exclusion Criteria:
- Any significant current medical conditions that would contraindicate smoking
- 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
Locations and Contacts
Yale Center for Clinical Investigations, Yale University, New Haven, Connecticut 06519, United States
Additional Information
Starting date: February 2013
Last updated: April 13, 2015
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