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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA033597 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxazosin 4mg/day | Experimental | doxazosin 4mg/day |
|
| Placebo | Placebo Comparator | placebo control |
|
| Doxazosin 8mg/day | Experimental | doxazosin 8mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxazosin 4mg/day | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry A McKee, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Center for Clinical Investigations, Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo controlled |
| FG001 | 4mg/Day | doxazosin 4mg/day Doxazosin: 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. |
| FG002 | 8mg/Day | doxazosin 8mg/day Doxazosin: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo controlled |
| BG001 | 4mg/Day | doxazosin 4mg/day Doxazosin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | minutes | 0 up to 50 minutes (Delay Period) |
|
Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo controlled | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry McKee, PhD | Yale School of Medicine | 203-737-3529 | sherry.mckee@yale.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D017292 | Doxazosin |
| ID | Term |
|---|---|
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Placebo | Drug | Placebo |
|
| Doxazosin 8mg/day | 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. |
|
|
| BG002 | 8mg/Day | doxazosin 8mg/day Doxazosin: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | 8mg/Day | doxazosin 8mg/day Doxazosin: 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. |
|
|
| 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. | Posted | Mean | Standard Error | number of cigarettes | 60 minutes (ad-lib smoking period) |
|
|
|
| 11 |
| 0 |
| 11 |
| 4 |
| 11 |
| EG001 | 4mg/Day | doxazosin 4mg/day Doxazosin: 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. | 0 | 11 | 0 | 11 | 6 | 11 |
| EG002 | 8mg/Day | doxazosin 8mg/day Doxazosin: 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. | 0 | 13 | 0 | 13 | 7 | 13 |
| Headache | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Back pain | General disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Fast heartbeat | Cardiac disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Abnormal vision | General disorders | Systematic Assessment |
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| Impotence | General disorders | Systematic Assessment |
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| Urinary tract infection | General disorders | Systematic Assessment |
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| Increased sweating | General disorders | Systematic Assessment |
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| Anxiety | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
|