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Modeling Stress-precipitated Smoking Behavior for Medication Development

Yale University logo

Yale University

Status and phase

Completed
Phase 2

Conditions

Smoking

Treatments

Drug: guanfacine
Drug: placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00773357
RL1DA024857 (U.S. NIH Grant/Contract)
0808004163
P50DA033945 (U.S. NIH Grant/Contract)
U54AA027989 (U.S. NIH Grant/Contract)
P01AA027473 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

Guanfacine
Experimental group
Description:
guanfacine 3mg/day
Treatment:
Drug: guanfacine
Placebo
Placebo Comparator group
Description:
placebo control
Treatment:
Drug: placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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