Modeling Stress-precipitated Smoking Behavior for Medication Development
5 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedResults Posted
Study results publicly available
August 1, 2022
CompletedAugust 3, 2022
August 1, 2022
12.8 years
October 14, 2008
July 7, 2022
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Latency to Initiate Ad-lib Smoking Session
latency to initiate smoking (in minutes) during a 50-minute period.
50 minutes
Study Arms (2)
Guanfacine
EXPERIMENTALguanfacine 3mg/day
Placebo
PLACEBO COMPARATORplacebo control
Interventions
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.
Eligibility Criteria
You may qualify if:
- ages 18-60
- able to read and write in English
- smokers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- Office of Research on Women's Health (ORWH)collaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (1)
Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sherry McKee
- Organization
- Yale School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Sherry A McKee, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 16, 2008
Study Start
October 1, 2008
Primary Completion
July 31, 2021
Study Completion
July 31, 2021
Last Updated
August 3, 2022
Results First Posted
August 1, 2022
Record last verified: 2022-08