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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773422
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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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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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773422


Locations
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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
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Principal Investigator: Sherry A McKee, PhD Yale University
More Information
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Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00773422    
Other Study ID Numbers: HIC0710003188
P50AA015632 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2008    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018
Last Verified: March 2018
Keywords provided by Sherry McKee, Yale University:
smoking lapse behavior
smoking cessation
varenicline
naltrexone
medication effect on smoking lapse behavior
Additional relevant MeSH terms:
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Naltrexone
Varenicline
Alcohol Deterrents
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