Modeling Stress-precipitated Smoking Behavior for Medication Development
This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Yale University
Collaborators:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00773357
First received: October 14, 2008
Last updated: February 21, 2013
Last verified: February 2013
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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
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: | February 21, 2013 |
| 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 May 22, 2013