Smoking CessationPhase 2NCT02051309
Guanfacine Clinical Trial for Smoking Cessation
A Phase 2 study testing Guanfacine in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Guanfacine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 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
Show all 20Show fewer
- 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
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
Official title: 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.
- Conditions
- Smoking Cessation
- Being tested
- Guanfacine, Placebo
- Keywords
- Smokers, Quit Smoking, Treatment, Guanfacine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Also called Intuniv
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.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine 6mg/day ER | Experimental | Guanfacine 6mg/day extended release Receives: Drug: Guanfacine |
| Placebo | Placebo comparator | Placebo matching capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Prolonged Smoking Abstinence
Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.
Measured: Week 3 to week 8 during 8-week treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2020
- Study completionNov 2020
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 Smoking CessationStudies 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, Care provider, Investigator
- Enrolment
- 121 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
- NCT02051309
- Sponsor's protocol ID
- 1110009133_B
- Other IDs
- R01DA035001
- Status last verified
- Nov 2021
- First submitted
- 14 Jan 2014
- Last updated
- 29 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02051309
- Acronym / sponsor ID
- 1110009133_B
- Conditions
- Smoking Cessation
- Keywords
- Smokers, Quit Smoking, Treatment, Guanfacine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2014
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Posted 29 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine 6mg/day ER | Experimental | Drug: GuanfacineGuanfacine 6mg/day extended release |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 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 screen for illicit drugs
- Past 30 days use of any 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 |
|---|---|---|
| GuanfacineAlso: Intuniv6mg/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. | Drug | Guanfacine 6mg/day ER |
| Placebo | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- 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 Guanfacine in people with Smoking Cessation, 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 5 inclusion and 20 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 29 Dec 2021. 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 29 Dec 2021). 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?
Rates of Prolonged Smoking Abstinence (time frame: Week 3 to week 8 during 8-week treatment phase). 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 29 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.