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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smoking

Intervention: Doxazosin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Latency (min) to initiate ad-lib smoking session

Secondary outcome:

Number of cigarettes smoked during ad-lib session

Days to first lapse during quit attempt

End of treatment 7-day point prevalence

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: February 2013
Last updated: April 13, 2015

Page last updated: August 23, 2015

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