Modafinil As A Pharmaceutical Treatment Of Alcohol Addiction

Modafinil (2-[(diphenylmethyl) sulfinyl] acetamide) is becoming more and more well known as a cognitive enhancer though it is in fact licensed as a drug to treat certain sleep disorders such as narcolepsy. Modafinil has been shown to have beneficial effects on memory, learning and attention but its mechanism of action has yet to be described in detail (Mereu, Bonci, Newman, & Tanda, 2013). Chronic drug use is often associated with cognitive impairments like poor response inhibition functions or deficits in working memory and attention. These impairments may have detrimental effects on treatment response as well as outcome. Hence, many studies have focused on using modafinil as a pharmaceutical treatment for substance use disorder. Cocaine and modafinil have been the focus of these studies so far but none have investigated alcohol dependency yet. Even though no clinical trial has been done to this date, that does not mean that the relationship between alcohol dependency and modafinil has not been investigated. In one study that examined this interaction, it was concluded that modafinil lowers performance in a digit span working memory test but increases verbal short term memory (Joos, Goudriaan, Schmaal, Brink, Sabbe & Dom 2013).

Methods

The study will use a randomized double-blind placebo-controlled design with an modafinil (300 mg) and a placebo in the form of lactose condition. Patients will be randomized to the placebo or modafinil. All research personnel should be blind to the medication assignment until the study will conclude. SubjectsParticipants must be seeking treatment and be alcohol dependent (AD). Patients also have to be between 18–60 years. Eligibility will be defined by examining their psychiatric history using to the MINI-plus International Neuropsychiatric Interview (Van Vliet and De Beurs, 2007) and their clinical history will be evaluated. There will also be laboratory tests done such as blood tests, liver functionality tests, urinalysis and a electrocardiogram. To be more exact the patients need a current diagnosis of DSM-IV alcohol dependence. The patients can not be diagnosed with any other substance dependence other than alcohol or be using other medications, neither can they have a clinical history of psychotic disorders. Additional exclusion criteria for AD patients include any modafinil and/or lactose intolerance, and for pregnant women who are breastfeeding. All participants will be paid 40 Euro as compensation for partaking.

Measures

Cognitive functions

The cognitive functions of the subjects will be examined using multiple cognitive tests. In order to check the verbal working memory the digit span test. The patient will have to recall a span of digits and say it in reverse. This will be used as the primary determinant of verbal working memory. Furthermore the IQ test will be used to assess a person’s intelligence. The Stroop Color and Word Test is a used to examine the ability to stop cognitive interference that happens when 2 separate cognitive signals impede each others cognition and processing, this is called the Stroop effect. Names of color are printed in a different color than they describe and the subject has to read them as fast as possible.

Procedures Recruitment

Vital information and the characteristic of the patient should be inquired about during an interview. Average alcohol use in the last 30 days before admission and the number of abstinence days before cognitive testing were surveyed with a Timeline Follow Back interview (Sobell and Sobell, 1992). Furthermore, years of heavy drinking should be assessed, defined as drinking alcohol at least three times a week (regardless of the dosage) or during two consecutive days.

The experiment

For the subjects, testing should take place when they are completely sober and are not taking any benzodiazepines. The AD subjects should be tested in the middle of the research and at the end. It is expected that cognitive functions should improve with modafinil between the beginning of the experiment and the middle. Furthermore, basing on previous research of Swanson et al. (2006) who did not find any rebound effect of modafinil (two week follow-up) after discontinuation, we believe that these improvements should be visible also after the experiment. Medication should be administered by a research staff member, if a patient is participating from home the administration should be confirmed by returned empty containers. All subjects should be screened for drug and alcohol use using urine and blood samples. Relapse of a patient should not be seen as a reason to discontinue the subjects participation in the research,although subjects should not be under influence while performing the tests.