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

Yale University35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Smoking

Interventions

Doxazosin 4mg/dayDRUG

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.

PlaceboDRUG

Placebo

Doxazosin 8mg/dayDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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