Phase 2
Completed N=30
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Source: ClinicalTrials.gov NCT00773422 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Latency to Initiate Ad-lib Smoking Session — 28.134; 45.861; 21.737 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Initiate Ad-lib Smoking Session |
28.134; 45.861; 21.737 | — |
| SECONDARY Number of Cigarettes Smoked During the Ad-lib Period |
1.283; 0.959; 2.23 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00773422). 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.