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Modeling Stress-precipitated Smoking Behavior for Medication Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773357
Recruitment Status : Active, not recruiting
First Posted : October 16, 2008
Last Update Posted : October 28, 2019
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Drug: guanfacine Drug: placebo Drug: Carvedilol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modeling Stress-precipitated Smoking Behavior for Medication Development
Study Start Date : October 2008
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. latency to initiate ad-lib smoking session [ Time Frame: during the laboratory sessions ]

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

Information from the National Library of Medicine

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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 Diagnostic and Statistical Manual IV (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 Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women; known intolerance for guanfacine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773357

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United States, Connecticut
Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
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Principal Investigator: Sherry A McKee, PhD Yale University

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Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University Identifier: NCT00773357     History of Changes
Other Study ID Numbers: 0808004163
RL1DA024857 ( U.S. NIH Grant/Contract )
P50DA033945 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Sherry McKee, Yale University:
smoking lapse behavior
smoking cessation
medication effect on smoking lapse behavior
medication effect on smoking cessation
gender differences
Additional relevant MeSH terms:
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Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists