NCT02051309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 29, 2021

Completed
Last Updated

December 29, 2021

Status Verified

November 1, 2021

Enrollment Period

6.7 years

First QC Date

January 14, 2014

Results QC Date

November 30, 2021

Last Update Submit

November 30, 2021

Conditions

Smoking Cessation

Keywords

SmokersQuit SmokingTreatmentGuanfacine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Guanfacine 6mg/day ER

EXPERIMENTAL

Guanfacine 6mg/day extended release

Drug: Guanfacine

Placebo

PLACEBO COMPARATOR

Placebo matching capsule

Drug: Placebo

Interventions

GuanfacineDRUG

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.

Also known as: Intuniv
Guanfacine 6mg/day ER
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Sherry McKee PhD
Organization
Yale School of Medicine
sherry.mckee@yale.edu
2037373529

Study Officials

  • Sherry A McKee, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 31, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

December 29, 2021

Results First Posted

December 29, 2021

Record last verified: 2021-11

Locations

US(1)