Trial record 6 of 53 for:    guanfacine

Guanfacine Clinical Trial for Smoking Cessation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT02051309
First received: January 14, 2014
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Smoking Cessation
Drug: Guanfacine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Rates of prolonged smoking abstinence [ Time Frame: At the end of the 8-week treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point prevalence and continuous abstinence [ Time Frame: At the end of the 8-week treatment period ] [ Designated as safety issue: No ]
    Measures will be assessed with a combination of self-reported tobacco use and biochemical confirmation including breath Carbon Monoxide (CO) levels and cotinine levels.

  • Prolonged smoking abstinence, 7-day point prevalence and continuous abstinence [ Time Frame: At the end of the 6-month follow-up period ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assess cigarette craving [ Time Frame: Baseline, Weeks 1-8, and 1, 2 & 6 month follow up ] [ Designated as safety issue: No ]
    Self report measure (Tiffany Questionnaire of Smoking Urges-Brief) will be used to assess cigarette craving.


Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051309

Contacts
Contact: Sabrina Coppola 203-737-2827
Contact: Kristin Good 203-785-2064

Locations
United States, Connecticut
Yale Center for Clinical Investigations, Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Sabrina Pizzola    203-737-2827      
Contact: Kristin Good    203-785-2064      
Principal Investigator: Sherry A McKee, PhD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

No publications provided

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02051309     History of Changes
Other Study ID Numbers: 1110009133_B, R01DA035001
Study First Received: January 14, 2014
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Smokers
Quit Smoking
Treatment
Guanfacine

Additional relevant MeSH terms:
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014