DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smoking

Intervention: naltrexone (Drug); varenicline (Drug); placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: latency to initiate ad-lib smoking session

Secondary outcome: number of cigarettes smoked during the ad-lib period

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Yale Center for Clinical Investigation, Yale University, New Haven, Connecticut 06519, United States
Additional Information

Starting date: January 2008
Last updated: April 13, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017