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

This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT01730846
First received: November 9, 2012
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  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: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Latency (min) to initiate ad-lib smoking session [ Time Frame: Lab Sessions (Day 20, 22) ] [ Designated as safety issue: No ]
    Latency to start smoking (min)


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: 60
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730846

Contacts
Contact: Meaghan Lavery 203-737-2783 meaghan.lavery@yale.edu

Locations
United States, Connecticut
Yale Center for Clinical Investigations, Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Meaghan Lavery     203-737-2783     meaghan.lavery@yale.edu    
Principal Investigator: Sherry A McKee, PhD            
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

No publications provided

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01730846     History of Changes
Other Study ID Numbers: 1111009293, R21DA033597
Study First Received: November 9, 2012
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Habits
Doxazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013