Phase 2
Completed N=150
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
Hazardous Drinking · Cigarette Smoking
Source: ClinicalTrials.gov NCT00938886 ↗
Enrolled (actual)
150
Serious AEs
1.3%
Results posted
May 2017
Primary outcomePrimary: Percent Heavy Drinking Days — 11.1; 11.4 percentage of days
Summary
To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Heavy Drinking Days |
11.1; 11.4 | — |
| SECONDARY 7-day Point Prevalence Smoking Abstinence |
9; 9 | — |
Eligibility Criteria
Inclusion Criteria
- 1.) 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 Criteria
- 1.) 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.
Data sourced from ClinicalTrials.gov (NCT00938886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.