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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00773422
First received: October 14, 2008
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Smoking
Drug: naltrexone
Drug: varenicline
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773422

Locations
United States, Connecticut
Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

No publications provided

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00773422     History of Changes
Other Study ID Numbers: HIC0710003188, P50AA15632
Study First Received: October 14, 2008
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014