Modeling Stress-precipitated Smoking Behavior for Medication Development

Smoking Clinical Trial

Official title:

Modeling Stress-precipitated Smoking Behavior for Medication Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773357
• Other study ID #: 0808004163
• Secondary ID: RL1DA024857P50DA
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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.
• placebo
placebo

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation, Yale University	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to Initiate Ad-lib Smoking Session	latency to initiate smoking (in minutes) during a 50-minute period.	50 minutes