Modeling Stress-precipitated Smoking Behavior for Medication Development

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.

Completed

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Key information

Conditions

Smoking Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Guanfacine

Drug

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 names: Tenex

Placebo

Drug

placebo

Primary outcomes

Latency to Initiate Ad-lib Smoking Session

Time frame: 50 minutes

latency to initiate smoking (in minutes) during a 50-minute period.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)

Registry information

Important dates

Study start: 2008
Primary completion: 2021
Study completion: 2021
First posted: Oct 16, 2008
Registry last updated: Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed