N/A
Completed N=64
A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence
Substance Dependence
Source: ClinicalTrials.gov NCT01011907 ↗
Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Feb 2013
Primary outcomePrimary: Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. — 788.94; 403.24 cigarettes
Summary
Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. |
788.94; 403.24 | — |
| SECONDARY Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12. |
277.5; 177.04 | — |
| SECONDARY Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study. |
-3.07; -4.36 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 21 and 75 years.
- Currently seeking treatment for nicotine dependence (smoke at least 10 cigarettes daily) and found to have problem drinking, alcohol abuse or alcohol dependence (non-physiological) as determined by amount of alcohol consumed weekly (Average weekly alcohol consumption (last 30 days), >7 standard drinks (for women) or >14 standard drinks (for men), clinical interview, and AUDIT score > 8.
- Generally healthy, without serious or unstable medical/mental illness(es).
- Smokers only will be included (degree of nicotine dependence will be assessed and included in analysis).
- Able to give voluntary, written, informed consent
Exclusion Criteria
- More than 30 days of abstinence from alcohol in the prior 90 days.
- History of major alcohol-related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, liver function tests > 3 X ULN).
- Intolerance to the study medication.
- Current psychiatric disorder(s) requiring clinical treatment.
- Any recent history (i.e. within the preceding 5 years) of suicide attempt or current suicidal ideation.
- Use of illicit or non-prescribed psychotropic drug use (opiates, benzodiazepines, cocaine, PCP, methamphetamine, cocaine, or marijuana more than twice a week).
- A history of complicated alcohol or other drug withdrawal syndrome(s), e.g.: delirium tremens or seizures.
Data sourced from ClinicalTrials.gov (NCT01011907). 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.