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

January 22, 2018 updated by: Sherry McKee, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Center for Clinical Investigations, Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxazosin 4mg/day
doxazosin 4mg/day
Drug: Doxazosin 4mg/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.
Other Names:
  • Cardura
Placebo Comparator: Placebo
placebo control
Drug: Placebo
Placebo
Experimental: Doxazosin 8mg/day
doxazosin 8mg/day
Drug: Doxazosin 8mg/day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 up to 50 minutes (Delay Period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes (ad-lib smoking period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111009293
  • R21DA033597 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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