Guanfacine Clinical Trial for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02051309
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : November 8, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Guanfacine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation
Study Start Date : March 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Guanfacine 6mg/day ER
Guanfacine 6mg/day extended release
Drug: Guanfacine
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 Name: Intuniv
Placebo Comparator: Placebo
Placebo matching capsule
Drug: Placebo

Primary Outcome Measures :
  1. Rates of prolonged smoking abstinence [ Time Frame: At the end of the 8-week treatment phase ]

Secondary Outcome Measures :
  1. 7-day point prevalence and continuous abstinence [ Time Frame: At the end of the 8-week treatment period ]
    Measures will be assessed with a combination of self-reported tobacco use and biochemical confirmation including breath Carbon Monoxide (CO) levels and cotinine levels.

  2. Prolonged smoking abstinence, 7-day point prevalence and continuous abstinence [ Time Frame: At the end of the 6-month follow-up period ]

Other Outcome Measures:
  1. Assess cigarette craving [ Time Frame: Baseline, Weeks 1-8, and 1, 2 & 6 month follow up ]
    Self report measure (Tiffany Questionnaire of Smoking Urges-Brief) will be used to assess cigarette craving.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02051309

United States, Connecticut
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sherry A McKee, PhD Yale University

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University Identifier: NCT02051309     History of Changes
Other Study ID Numbers: 1110009133_B
R01DA035001 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Sherry McKee, Yale University:
Quit Smoking

Additional relevant MeSH terms:
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs