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Modeling Stress-precipitated Smoking Behavior for Medication Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Yale University
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Sherry McKee, Yale University Identifier:
First received: October 14, 2008
Last updated: November 22, 2016
Last verified: November 2016
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 (Participant, 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 ]

Secondary Outcome Measures:
  • number of cigarettes smoking during the ad-lib period [ Time Frame: during the laboratory sessions ]
  • success rates in smoking cessation attempt [ Time Frame: during smoking cessation attempt ]
  • gender differences in medication effects [ Time Frame: lab session and smoking cessation attempt ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University Identifier: NCT00773357     History of Changes
Other Study ID Numbers: HIC0808004163
RL1DA024857 ( US NIH Grant/Contract Award Number )
P50DA033945 ( US NIH Grant/Contract Award Number )
Study First Received: October 14, 2008
Last Updated: November 22, 2016

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:
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists processed this record on April 25, 2017