Guanfacine Clinical Trial for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051309
• Other study ID #: 1110009133_B
• Secondary ID: R01DA035001
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: November 2020

Study information

• Verified date: November 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• Placebo

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigations, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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