Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RL1DA024857 | U.S. NIH Grant/Contract | View source | |
| P50DA033945 | U.S. NIH Grant/Contract | View source | |
| P01AA027473 | U.S. NIH Grant/Contract | View source | |
| U54AA027989 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Office of Research on Women's Health (ORWH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine | Experimental | guanfacine 3mg/day |
|
| Placebo | Placebo Comparator | placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guanfacine | Drug | 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Initiate Ad-lib Smoking Session | latency to initiate smoking (in minutes) during a 50-minute period. | 50 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherry A McKee, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Center for Clinical Investigation, Yale University | New Haven | Connecticut | 06519 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine | guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study. |
| FG001 | Placebo | placebo control placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine | guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of 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 to Initiate Ad-lib Smoking Session | latency to initiate smoking (in minutes) during a 50-minute period. | Posted | Mean | Standard Error | minutes | 50 minutes |
|
Titration period of 21 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guanfacine | guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dry mouth | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry McKee | Yale School of Medicine | 2037373529 | sherry.mckee@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2022 | Jul 7, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| placebo | Drug | placebo |
|
| BG001 |
| Placebo |
placebo control placebo: placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 35 |
| 50 |
| EG001 | Placebo | placebo control placebo: placebo | 0 | 50 | 0 | 50 | 12 | 50 |
| Drowsiness | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Impotence | Reproductive system and breast disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |