Modeling Stress-precipitated Smoking Behavior for Medication Development

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: guanfacine; Drug: placebo

• Registration Number: NCT00773357
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Results First Submitted: 2022-07-07
• Results First Submitted QC: 2022-07-07
• Status Verified: 2022-08
• Results First Posted: 2022-08-01
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ages 18-60
• able to read and write in English
• smokers

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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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guanfacine	guanfacine	guanfacine 3mg/day
Placebo	placebo	placebo control

Primary Outcome Measures

Name	Time	Method
Latency to Initiate Ad-lib Smoking Session	50 minutes	latency to initiate smoking (in minutes) during a 50-minute period.

Trial Locations

Locations (1)

Yale Center for Clinical Investigation, Yale University; 🇺🇸 New Haven, Connecticut, United States