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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730846
• Other study ID #: 1111009293
• Secondary ID: R21DA033597
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2012
• Last updated: January 22, 2018
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• 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.
• Placebo
Placebo
• 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.

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigations, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)