- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051309
Guanfacine Clinical Trial for Smoking Cessation
November 30, 2021 updated by: Sherry McKee, Yale University
Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation
Adult daily smokers motivated to quit smoking will be randomized to extended-release guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining medication with brief behavioral support.
The investigators hypothesize that the active dose of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the end of the 8-week treatment phase.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Yale Center for Clinical Investigations, Yale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-65
- Able to read, write and comprehend English
- Smoker
- Able to take oral medications and willing to adhere to a medication regimen
- Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems
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 screen for illicit drugs
- Past 30 days use of any psychoactive drugs including anxiolytics and antidepressants
- Women who are pregnant or nursing
- Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
- Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
- Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days
- Only one member per household can participate in the study
- Specific exclusions for administration of guanfacine not already specified include:
- EKG evidence at baseline screening for any clinically significant conduction abnormalities or arrhythmias
- Known intolerance for guanfacine or any alpha blocker
- History of fainting, syncopal attacks
- Heart failure or myocardial infarction
- Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3x normal)
- Renal function (as indicated by estimated creatinine clearance <60cc/min)
- Treatment with any antihypertensive drug or any alpha-adrenergic blocker
- Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice
- Subjects may not have donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guanfacine 6mg/day ER
Guanfacine 6mg/day extended release
|
6mg/day ER with 3-week lead-in period.
Maintained at steady state throughout 8 week treatment phase.
After treatment phase, given taper supply of medication.
Follow up at 1 month, 2 months and 6 months.
Other Names:
|
Placebo Comparator: Placebo
Placebo matching capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of Prolonged Smoking Abstinence
Time Frame: Week 3 to week 8 during 8-week treatment phase
|
Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.
|
Week 3 to week 8 during 8-week treatment phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
January 14, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1110009133_B
- R01DA035001 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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