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Completed

NCT Number: NCT00773422

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

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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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

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

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).

Other names: Chantix

Placebo

Drug

placebo

Primary outcomes

  1. Latency to Initiate Ad-lib Smoking Session

    Time frame: day 8

    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.

Secondary outcomes

  1. Number of Cigarettes Smoked During the Ad-lib Period

    Time frame: day 8

    Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2008
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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