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

NCT ID: NCT01730846

Last Updated: 2018-02-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Doxazosin 4mg/day

doxazosin 4mg/day

Group Type EXPERIMENTAL

Doxazosin 4mg/day

Intervention Type DRUG

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.

Placebo

placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Doxazosin 8mg/day

doxazosin 8mg/day

Group Type EXPERIMENTAL

Doxazosin 8mg/day

Intervention Type DRUG

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.

Interventions

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Doxazosin 4mg/day

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.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Doxazosin 8mg/day

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.

Intervention Type DRUG

Other Intervention Names

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Cardura Cardura

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Sherry McKee

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherry A McKee, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R21DA033597

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1111009293

Identifier Type: -

Identifier Source: org_study_id

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