The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Information source: Yale University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking
Intervention: naltrexone (Drug); varenicline (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
Overall contact:
Sabrina Coppola, Phone: 203-737-2827
Summary
The purpose of this stuy is to examine how medications thought to attenuate the effects of
alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to
resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming
drink, in non-treatment seeking alcohol-drinking daily smokers.
Clinical Details
Official title: The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Primary outcome: latency to initiate ad-lib smoking session
Secondary outcome: number of cigarettes smoked during the ad-lib period
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ages 21-55
- ability to read and write in English
- alcohol-drinking smokers
Exclusion Criteria:
- any significant current medical conditions that would contraindicate smoking
- current DSM-IV abuse or dependence of other substances, other than nicotine dependence
or alcohol abuse.
- 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 current severe mental illness
- participants prescribed any psychotropic drug in the 30 days prior to study
enrollment
- blood donation within the past 6 weeks
- individuals seeking treatment for smoking cessation or drinking or have attempted to
quit smoking or drinking within the past 3 months
- specific exclusion for administration of naltrexone not specified above including
chronic pain conditions necessitating opioid treatment, and evidence of significant
hepatocellular injury as evidenced by SGOT or SGPT > 3x normal or elevated bilirubin
- known allergy to varenicline or taking H2blockers (e. g., Cimetidine)
- participation within the past 8 weeks in other studies that involve additive blood
sampling and/or interventional measures that would be considered excessive in
combination with the current protocol
Locations and Contacts
Sabrina Coppola, Phone: 203-737-2827
Yale Center for Clinical Investigation, Yale University, New Haven, Connecticut 06519, United States; Recruiting
Additional Information
Starting date: January 2008
Ending date: August 2010
Last updated: October 15, 2008
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