Official Title: “Modeling Stress-precipitated Smoking Behavior for Medication Development: Guanfacine”

The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers. Participants seeking treatment for smoking will participate in a smoking cessation attempt after the laboratory sessions.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment

Study Primary Completion Date: October 2013

Intervention(s) in this Clinical Trial

• Drug: guanfacine
  • 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Guanfacine
  • guanfacine 3mg/day
• Placebo Comparator: Placebo
  • placebo control

Primary Measures

• latency to initiate ad-lib smoking session
  • Time Frame: during the laboratory sessions
    Safety Issue?: No

Secondary Measures

• number of cigarettes smoking during the ad-lib period
  • Time Frame: during the laboratory sessions
    Safety Issue?: No
• success rates in smoking cessation attempt
  • Time Frame: during smoking cessation attempt
    Safety Issue?: No

Inclusion Criteria:

• ages 18-60
• able to read and write in English
• smokers

Exclusion Criteria:

• any significant current medical conditions that would contraindicate smoking
• current DSM-IV abuse or dependence of other substances, other than nicotine (or caffeine) dependence
• positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
• women who are pregnant or nursing
• suicidal, homicidal or evidence of severe mental illness
• participants prescribed any psychotropic drug in the 30 days prior to study enrollment
• blood donation within the past 6 weeks
• participants who have engaged in a quit attempt in the past 3 months
• specific exclusions for administration of guanfacine not already specified include:
• Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazlett's QTc >450 msec for men and QTc>470 msec for women; known intolerance for guanfacine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Sherry A McKee, PhD Principal Investigator Yale University  

Overall Contact: Meaghan Lavery 203-974-7603 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00773357

Study ID Number: HIC0808004163

ClinicalTrials.gov Identifier: NCT00773357

Health Authority: United States: Institutional Review Board