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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-11-30

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.

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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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naltrexone + varenicline

naltrexone (25mg) + varenicline (2mg)

Group Type EXPERIMENTAL

naltrexone

Intervention Type DRUG

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).

varenicline

Intervention Type DRUG

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

varenicline 2mg

Group Type EXPERIMENTAL

varenicline

Intervention Type DRUG

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 control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Chantix

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No