Alcohol dependent patients and/or polysubstance abusers with alcohol addiction as the primary problem
Conditions
Interventions
MODAFINIL GROUP:
1. 300mg/day
2. Single dose
3. Oral administration
4. (3 x 1 tablet of 100mg/day) during 10 weeks.
Adminstration scheme:
1. Day 1-5 : 100mg/day
2. Day 6-10: 200mg/day
3. Day 11-70: 300mg/day.
CONTROL GROUP:
1. Placebo tablets, containing lactose (3 x 1 tablet)
2. Comparable administration and administration scheme as the modafinil group.
Sponsors
- Amsterdam Medical Center; Amsterdam Institute for Addiction Research (AMC; AIAR),
- University of Antwerp; Collaborative Antwerp Psychiatric Research Institute (UA; CAPRI)
- Psychiatric Centre Alexian Brothers (Boechout; Belgium)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Current DSM-IV diagnosis of alcohol dependence, but recently detoxified and abstinent and not using benzodiazepines for a least one week; 2. 18-60 years; 3. Male/female; 4. Signed informed consent; 5. Following the behavioural treatment programme.
Exclusion criteria
Exclusion criteria: 1. Illiteracy - restricted knowledge of Dutch; 2. Mental retardation (IQ < 75); 3. Colour blindness; 4. Current use of prescription or illicit psychoactive drugs; 5. Lifetime history of head injury with loss of consciousness for more than 5 minutes; 6. Serious neurological or psychiatric disorders (e.g. psychosis, dementia, bipolar disorder, antisocial personality disorder, major depressive disorder, anxiety disorder, sleep disorder); 7. Being on an active low-calorie diet (<1000 calories/day); 8. Being pregnant, planning to become pregnant, or breast feading; 9. Unstable medical illness (e.g. hypertension, diabetes, myocardial infarct). With respect to modafinil: 1. Use of medication affecting the central nerve system (e.g. benzodiazepines, anti-depressants,…); 2. Hypersensitivity for modafinil and lactose; 3. Any disease of the gastrointestinal system, liver or kidneys.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Test performance (on both neurocognitive tests and self-report questionnaires); 2. Craving ratings; 3. Relapse (in terms of quantity/frequency measures of alcohol use). | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement or deterioration of specific characteristics (such as depression, ADHD symptoms, anhedonia, fatigue), due to the intervention of modafinil. | — |
Contacts
Public ContactLeen Joos
Outcome results
None listed