Modeling Stress-precipitated Smoking Behavior for Medication Development

This study is currently recruiting participants.
Verified April 2014 by Yale University
Information provided by (Responsible Party):
Sherry McKee, Yale University Identifier:
First received: October 14, 2008
Last updated: April 8, 2014
Last verified: April 2014

The purpose of this study is to examine whether guanfacine or carvedilol 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. Also looking at gender differences.

Condition Intervention Phase
Drug: guanfacine
Drug: placebo
Drug: Carvedilol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modeling Stress-precipitated Smoking Behavior for Medication Development

Resource links provided by NLM:

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 ]
  • gender differences in medication effects [ Time Frame: lab session and smoking cessation attempt ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guanfacine
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.
Other Name: Tenex
Placebo Comparator: Placebo
placebo control
Drug: placebo
Experimental: Carvedilol
Carvedilol 50 mg/day
Drug: Carvedilol
50 mg/day titrated to stead state. The starting dose is 12.5 mg/day for day 1, followed by 25 mg/day for days 2-3, followed by 50 mg from days 4 to the end of the study.
Other Name: Coreg


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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/carvedilol 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 identifier: NCT00773357

Contact: Meaghan Lavery 203-737-2738

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
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

No publications provided

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University Identifier: NCT00773357     History of Changes
Other Study ID Numbers: HIC0808004163, RL1DA024857, P50DA033945
Study First Received: October 14, 2008
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
smoking lapse behavior
smoking cessation
medication effect on smoking lapse behavior
medication effect on smoking cessation
gender differences

Additional relevant MeSH terms:
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists processed this record on April 14, 2014