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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Sherry McKee, Yale University

ClinicalTrials.gov Identifier:

NCT00773422

First received: October 14, 2008

Last updated: May 6, 2016

Last verified: May 2016

History of Changes

Purpose

The purpose of this study 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 2


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

Resource links provided by NLM:

MedlinePlus related topics: Smoking

Drug Information available for: Naltrexone Naltrexone hydrochloride Varenicline Varenicline tartrate

U.S. FDA Resources

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:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: naltrexone + varenicline 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). Other Name: Chantix
Experimental: varenicline 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). Other Name: Chantix
Placebo Comparator: placebo placebo control	Drug: placebo placebo

Eligibility


Ages Eligible for Study:	21 Years to 55 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Yale University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Principal Investigator:	Sherry A McKee, PhD	Yale University

More Information


Responsible Party:	Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT00773422 History of Changes
Other Study ID Numbers:	HIC0710003188 P50AA015632
Study First Received:	October 14, 2008
Last Updated:	May 6, 2016
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

Additional relevant MeSH terms:


Naltrexone Varenicline Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents	Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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