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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Smoking	Drug: naltrexone; Drug: varenicline; Drug: placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Study Start Date :	January 2008
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	November 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ]

Secondary Outcome Measures :

1. number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( U.S. NIH Grant/Contract )
First Posted:	October 16, 2008
Last Update Posted:	November 23, 2016
Last Verified:	November 2016

Keywords provided by Sherry McKee, 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