The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse - Full Text View

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00773422

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: naltrexone Drug: varenicline Drug: placebo	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Naltrexone Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Official Title:	The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Further study details as provided by Yale University:

Primary Outcome Measures:

latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
naltrexone + varenicline: Experimental naltrexone (25mg) + varenicline (2mg)	Drug: naltrexone 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). Drug: varenicline 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
varenicline: Experimental varenicline 2mg	Drug: varenicline 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
placebo: Placebo Comparator placebo control	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773422

Contacts

Contact: Sabrina Coppola

203-737-2827

Locations

United States, Connecticut
Yale Center for Clinical Investigation, Yale University	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Sherry A McKee, PhD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Sherry McKee )
Study ID Numbers:	HIC0710003188, P50AA15632
Study First Received:	October 14, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00773422
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

smoking lapse behavior
smoking cessation
varenicline
naltrexone
medication effect on smoking lapse behavior

Study placed in the following topic categories:

Smoking
Naltrexone
Ethanol

Additional relevant MeSH terms:

Habits
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009