Modeling Stress-precipitated Smoking Behavior for Medication Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00773357
First received: October 14, 2008
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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
Smoking
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
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

  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/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 ClinicalTrials.gov identifier: NCT00773357

Contacts
Contact: Meaghan Lavery 203-737-2738

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

No publications provided

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov 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
guanfacine
carvedilol
medication effect on smoking lapse behavior
medication effect on smoking cessation
stress
gender differences

Additional relevant MeSH terms:
Smoking
Habits
Carvedilol
Guanfacine
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

ClinicalTrials.gov processed this record on July 22, 2014