Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
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|ClinicalTrials.gov Identifier: NCT01730846|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : December 20, 2017
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: Doxazosin 4mg/day Drug: Placebo Drug: Doxazosin 8mg/day||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Doxazosin 4mg/day
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.
Other Name: Cardura
Placebo Comparator: Placebo
Experimental: Doxazosin 8mg/day
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.
Other Name: Cardura
- Latency (Min) to Initiate Ad-lib Smoking Session [ Time Frame: 0 up to 50 minutes (Delay Period) ]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.
- Number of Cigarettes Smoked During Ad-lib Session [ Time Frame: 60 minutes (ad-lib smoking period) ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730846
|United States, Connecticut|
|Yale Center for Clinical Investigations, Yale University|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Sherry A McKee, PhD||Yale University|