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

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: Placebo; Drug: Doxazosin 8mg/day; Drug: Doxazosin 4mg/day

• Registration Number: NCT01730846
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Study Start: 2013-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-11-20
• Results First Submitted QC: 2017-11-20
• Results First Posted: 2017-12-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Ages 18-60
• Able to read and write English
• Smoker
• Motivated to Quit Smoking

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo control
Doxazosin 8mg/day	Doxazosin 8mg/day	doxazosin 8mg/day
Doxazosin 4mg/day	Doxazosin 4mg/day	doxazosin 4mg/day

Primary Outcome Measures

Name	Time	Method
Latency (Min) to Initiate Ad-lib Smoking Session	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 Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked During Ad-lib Session	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.

Trial Locations

Locations (1)

Yale Center for Clinical Investigations, Yale University; 🇺🇸 New Haven, Connecticut, United States