Status:
COMPLETED
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
Lead Sponsor:
Brown University
Conditions:
Hazardous Drinking
Cigarette Smoking
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment.
Detailed Description
A substantial portion of individuals seeking behavioral and pharmacological treatment for smoking cessation drink excessively with many reporting significant alcohol problems. Although these at-risk a...
Eligibility Criteria
Inclusion
- ) be at least 18 years of age, 2.) drink heavily at least once per month on average (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.) currently be using no other tobacco products or nicotine replacement therapy
Exclusion
- ) meet criteria for current substance dependence (excluding nicotine and alcohol); 2.) report opiate use in the past month, have a drug screen positive for opiates, or require opiate containing medications for pain management; 3.) meet criteria for a current major depressive or manic episode; 4.) are currently psychotic or suicidal; 5.) have an unstable or serious medical condition that would preclude use of the nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia, recent congestive heart failure); 6.) have aspartate aminotransferase or alanine aminotransferase levels of more than 3 times the reference range or elevated bilirubin levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are not using a reliable means of birth control.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00938886
Start Date
October 1 2009
End Date
December 1 2015
Last Update
May 15 2017
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02912