Overview

This trial is active, not recruiting.

Condition smoking
Treatments doxazosin, placebo
Phase phase 2
Sponsor Yale University
Collaborator National Institute on Drug Abuse (NIDA)
Start date February 2013
End date December 2017
Trial size 60 participants
Trial identifier NCT01730846, 1111009293, R21DA033597

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
doxazosin 4mg/day doxazosin 8mg/day
doxazosin Cardura
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. 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.
(Placebo Comparator)
placebo control
placebo
Placebo

Primary Outcomes

Measure
Latency (min) to initiate ad-lib smoking session
time frame: Lab Sessions (Day 20, 22)

Secondary Outcomes

Measure
Number of cigarettes smoked during ad-lib session
time frame: Lab Sessions (Day 20, 22)
Days to first lapse during quit attempt
time frame: 4-wk smoking cessation attempt
End of treatment 7-day point prevalence
time frame: 4-wk smoking cessation attempt

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.