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

Study Overview
=================
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.

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

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: Doxazosin 4mg/day
* Drug: Placebo
* Drug: Doxazosin 8mg/day


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxazosin 4mg/day<br>doxazosin 4mg/day | Drug: Doxazosin 4mg/day<br>* 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.<br>* Other names: Cardura;|
| Placebo Comparator: Placebo<br>placebo control | Drug: Placebo<br>* Placebo<br>|
| Experimental: Doxazosin 8mg/day<br>doxazosin 8mg/day | Drug: Doxazosin 8mg/day<br>* 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.<br>* 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 | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking lapse behavior, smoking cessation, doxazosin, medication effect on smoking lapse behavior, medication effect on smoking cessation, stress