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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Drug: naltrexone
* Drug: varenicline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: naltrexone + varenicline<br>naltrexone (25mg) + varenicline (2mg) | Drug: naltrexone<br>* 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).<br>Drug: varenicline<br>* 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).<br>* Other names: Chantix;|
| Experimental: varenicline<br>varenicline 2mg | Drug: varenicline<br>* 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).<br>* Other names: Chantix;|
| Placebo Comparator: placebo<br>placebo control | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to Initiate Ad-lib Smoking Session | Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes. | day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cigarettes Smoked During the Ad-lib Period | Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study. | day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking lapse behavior, smoking cessation, varenicline, naltrexone, medication effect on smoking lapse behavior