SmokingPhase 2NCT01904526

PK/PD Comparison of Guanfacine ER and IR

A Phase 2 study testing Guanfacine in people with Smoking, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Guanfacine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Dec 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 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 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 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 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 of 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 have not 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

Other trials in United States

About this study

Official title: Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers

Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.

Conditions: Smoking
Being tested: Guanfacine
Keywords: Guanfacine, PK/PD, Smokers
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GuanfacineDrug
Also called Tenex, Intuniv
3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.

Study groups in NCT01904526
Study group	Role	What they receive
Guanfacine	Experimental	Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release Receives: Drug: Guanfacine

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Trough Levels of Guanfacine
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose
Measured: +24 hours on Lab Session days (Days 22, 49, 58)

Secondary outcomes (2)

Heart Rate
Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)
Measured: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)
Systolic Blood Pressure
Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)
Measured: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Dec 2016

First posted22 Jul 2013 (estimated)
Study startJul 2013
Primary completionDec 2016
Study completionDec 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904526
Sponsor's protocol ID: 1110009133
Other IDs: R01DA035001, P50DA033945
Status last verified: Mar 2020
First submitted: 12 Jul 2013
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers
ClinicalTrials.gov ID: NCT01904526
Acronym / sponsor ID: 1110009133
Conditions: Smoking
Keywords: Guanfacine, PK/PD, Smokers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jul 2013
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 22 Jul 2013 (estimated)
Results: Posted 23 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Guanfacine	Experimental	Drug: GuanfacineGuanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release

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 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 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
GuanfacineAlso: Tenex, Intuniv3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.	Drug	Guanfacine

Primary outcome

Plasma Trough Levels of Guanfacine
Time frame: +24 hours on Lab Session days (Days 22, 49, 58)
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose

2 secondary outcomes

Heart Rate
Time frame: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)
Systolic Blood Pressure
Time frame: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)

Results and safety

Results posted to the registry on 23 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guanfacine	5	5

Primary outcome: Plasma Trough Levels of Guanfacine

Time frame: +24 hours on Lab Session days (Days 22, 49, 58). Mean (Standard Error). Unit: ng/ml

Measure	Guanfacine 3mg/Day Immediate Release n = 5	Guanfacine 4mg/Day Extended Release n = 5	Guanfacine 6mg/Day Extended Release n = 5
Value	3.40 (0.33)	3.46 (0.67)	5.92 (1.02)

Population analysed: 3 mg/day IR (Day 22) followed by 4mg/day ER (Day 49) followed by 6mg/day ER (Day 58)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guanfacine 3mg/Day Immediate Release	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Guanfacine 4mg/Day Extended Release	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Guanfacine 6mg/Day Extended Release	0 of 5 (0%)	4 of 5 (80%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
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Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Recruiting
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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, 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 6 Mar 2020. 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. 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 23 Apr 2018). 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?

Plasma Trough Levels of Guanfacine (time frame: +24 hours on Lab Session days (Days 22, 49, 58)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904526.

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 6 Mar 2020.