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OpenTrials
Completed

NCT Number: NCT01730846

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

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxazosin 4mg/day

Drug

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.

Other names: Cardura

Placebo

Drug

Placebo

Doxazosin 8mg/day

Drug

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 names: Cardura

Primary outcomes

  1. Latency (Min) to Initiate Ad-lib Smoking Session

    Time frame: 0 up to 50 minutes (Delay Period)

    Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.

Secondary outcomes

  1. Number of Cigarettes Smoked During Ad-lib Session

    Time frame: 60 minutes (ad-lib smoking period)

    Number of cigarettes smoked during the stress and neutral ad-lib smoking period.

    Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2012
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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