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

October 14, 2008
April 8, 2014
October 2008
July 2017   (final data collection date for primary outcome measure)
latency to initiate ad-lib smoking session [ Time Frame: during the laboratory sessions ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773357 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Modeling Stress-precipitated Smoking Behavior for Medication Development
Modeling Stress-precipitated Smoking Behavior for Medication Development

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking
  • 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
  • Drug: placebo
    placebo
  • 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
  • Experimental: Guanfacine
    guanfacine 3mg/day
    Intervention: Drug: guanfacine
  • Placebo Comparator: Placebo
    placebo control
    Intervention: Drug: placebo
  • Experimental: Carvedilol
    Carvedilol 50 mg/day
    Intervention: Drug: Carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
July 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Meaghan Lavery 203-737-2738
United States
 
NCT00773357
HIC0808004163, RL1DA024857, P50DA033945
Yes
Sherry McKee, Yale University
Yale University
  • National Institute on Drug Abuse (NIDA)
  • Office of Research on Women's Health (ORWH)
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP