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Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730846
First Posted: November 21, 2012
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
  Purpose
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.

Condition Intervention Phase
Smoking Drug: Doxazosin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?

Resource links provided by NLM:


Further study details as provided by Sherry McKee, Yale University:

Primary Outcome Measures:
  • Latency (min) to initiate ad-lib smoking session [ Time Frame: Lab Sessions (Day 20, 22) ]
    Latency to start smoking (min)


Secondary Outcome Measures:
  • Number of cigarettes smoked during ad-lib session [ Time Frame: Lab Sessions (Day 20, 22) ]
    Number of cigarettes smoking during ad-lib session

  • Days to first lapse during quit attempt [ Time Frame: 4-wk smoking cessation attempt ]
    Days to first instance of smoking (even a puff)

  • End of treatment 7-day point prevalence [ Time Frame: 4-wk smoking cessation attempt ]
    Smoking (yes/no) during Week 4 of cessation attempt


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxazosin
doxazosin 4mg/day doxazosin 8mg/day
Drug: Doxazosin

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
placebo control
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730846


Locations
United States, Connecticut
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01730846     History of Changes
Other Study ID Numbers: 1111009293
R21DA033597 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2012
First Posted: November 21, 2012
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Sherry McKee, Yale University:
smoking lapse behavior
smoking cessation
doxazosin
medication effect on smoking lapse behavior
medication effect on smoking cessation
stress

Additional relevant MeSH terms:
Doxazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs