Guanfacine Clinical Trial for Smoking Cessation

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: Smoking Cessation
• Intervention / Treatment: Drug: Placebo; Drug: Guanfacine

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Center for Clinical Investigations, Yale University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Intuniv
Placebo Comparator: Placebo; Placebo matching capsule	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 3 to week 8 during 8-week treatment phase

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

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: Treatment; Smokers; Quit Smoking; Guanfacine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Guanfacine
• 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