SmokingPhase 2NCT01730846
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
A Phase 2 study testing Doxazosin 4mg/day and Doxazosin 8mg/day in people with Smoking, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Doxazosin 4mg/day and Doxazosin 8mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-60
- Able to read and write English
- Smoker
- Motivated to Quit Smoking
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, 06519
About this study
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.
- Conditions
- Smoking
- Being tested
- Doxazosin 4mg/day, Placebo, Doxazosin 8mg/day
- Keywords
- smoking lapse behavior, smoking cessation, doxazosin, medication effect on smoking lapse behavior, medication effect on smoking cessation, stress
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin 4mg/dayDrug
Also called 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.
PlaceboDrug
Placebo
Doxazosin 8mg/dayDrug
Also called Cardura
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.
| Study group | Role | What they receive |
|---|---|---|
| Doxazosin 4mg/day | Experimental | doxazosin 4mg/day Receives: Drug: Doxazosin 4mg/day |
| Placebo | Placebo comparator | placebo control Receives: Drug: Placebo |
| Doxazosin 8mg/day | Experimental | doxazosin 8mg/day Receives: Drug: Doxazosin 8mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 up to 50 minutes (Delay Period)
Secondary outcomes (1)
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.
Measured: 60 minutes (ad-lib smoking period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sherry McKee, Yale University
- Investigators
- Sherry A McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730846
- Sponsor's protocol ID
- 1111009293
- Other IDs
- R21DA033597
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2012
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
- ClinicalTrials.gov ID
- NCT01730846
- Acronym / sponsor ID
- 1111009293
- Conditions
- Smoking
- Keywords
- smoking lapse behavior, smoking cessation, doxazosin, medication effect on smoking lapse behavior, medication effect on smoking cessation, stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Posted 20 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doxazosin 4mg/day | Experimental | Drug: Doxazosin 4mg/daydoxazosin 4mg/day |
| Placebo | Placebo comparator | Drug: Placeboplacebo control |
| Doxazosin 8mg/day | Experimental | Drug: Doxazosin 8mg/daydoxazosin 8mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-60
- Able to read and write English
- Smoker
- Motivated to Quit Smoking
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxazosin 4mg/dayAlso: Cardura4 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. | Drug | Doxazosin 4mg/day |
| PlaceboPlacebo | Drug | Placebo |
| Doxazosin 8mg/dayAlso: Cardura8 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. | Drug | Doxazosin 8mg/day |
Primary outcome
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.
1 secondary outcome
Number of Cigarettes Smoked During Ad-lib Session
Time frame: 60 minutes (ad-lib smoking period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry A McKee, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxazosin 4mg/day and Doxazosin 8mg/day in people with Smoking, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency (Min) to Initiate Ad-lib Smoking Session (time frame: 0 up to 50 minutes (Delay Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.