Modeling Stress-Precipitated Smoking Behavior for Medication Development: Guanfacine - Full Text View

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00773357

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: guanfacine Drug: placebo	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Official Title:	Modeling Stress-Precipitated Smoking Behavior for Medication Development: Guanfacine

Further study details as provided by Yale University:

Primary Outcome Measures:

latency to initiate ad-lib smoking session [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of cigarettes smoking during the ad-lib period [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]
success rates in smoking cessation attempt [ Time Frame: during smoking cessation attempt ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Guanfacine: Experimental guanfacine 3mg/day	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.
Placebo: Placebo Comparator placebo control	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773357

Contacts

Contact: Meaghan Lavery

203-974-7603

Locations

United States, Connecticut
Yale Center for Clinical Investigation, Yale University	Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Sherry A McKee, PhD

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Sherry A McKee, PhD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Sherry McKee )
Study ID Numbers:	HIC0808004163, RL1DA024857
Study First Received:	October 14, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00773357
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

smoking lapse behavior
smoking cessation
guanfacine

medication effect on smoking lapse behavior
medication effect on smoking cessation
stress

Study placed in the following topic categories:

Smoking
Guanfacine
Stress

Additional relevant MeSH terms:

Habits
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009