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

Yale University

Status and phase: Completed; Phase 2

Conditions: Smoking

Treatments: Drug: Doxazosin 8mg/day; Drug: Doxazosin 4mg/day; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01730846

1111009293

R21DA033597 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

Doxazosin 4mg/day

Experimental group

Description:

doxazosin 4mg/day

Treatment:

Drug: Doxazosin 4mg/day

Placebo

Placebo Comparator group

Description:

placebo control

Treatment:

Drug: Placebo

Doxazosin 8mg/day

Experimental group

Description:

doxazosin 8mg/day

Treatment:

Drug: Doxazosin 8mg/day