Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
This study is ongoing, but not recruiting participants.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
First received: November 9, 2012
Last updated: May 6, 2016
Last verified: May 2016
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.
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Primary Outcome Measures:
Secondary Outcome Measures:
- Number of cigarettes smoked during ad-lib session [ Time Frame: Lab Sessions (Day 20, 22) ] [ Designated as safety issue: No ]
Number of cigarettes smoking during ad-lib session
- Days to first lapse during quit attempt [ Time Frame: 4-wk smoking cessation attempt ] [ Designated as safety issue: No ]
Days to first instance of smoking (even a puff)
- End of treatment 7-day point prevalence [ Time Frame: 4-wk smoking cessation attempt ] [ Designated as safety issue: No ]
Smoking (yes/no) during Week 4 of cessation attempt
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2017 (Final data collection date for primary outcome measure)
doxazosin 4mg/day doxazosin 8mg/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.
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 Name: Cardura
Placebo Comparator: Placebo
|Ages Eligible for Study:
||18 Years to 60 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Ages 18-60
- Able to read and write English
- Motivated to Quit Smoking
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01730846
|Yale Center for Clinical Investigations, Yale University
|New Haven, Connecticut, United States, 06519 |
National Institute on Drug Abuse (NIDA)
||Sherry A McKee, PhD
||Sherry McKee, Associate Professor of Psychiatry, Yale University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 9, 2012
||May 6, 2016
||United States: Institutional Review Board
Keywords provided by Yale University:
smoking lapse behavior
medication effect on smoking lapse behavior
medication effect on smoking cessation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2016
Adrenergic alpha-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs