|- candidate number||5513|
|- NTR Number||NTR1736|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2009|
|- Secondary IDs||31160003 Projectnumber ZonMw – programme risk behavior & substance dependency|
|- Public Title||Effects of long-term treatment with modafinil on relapse and impulse control in alcohol dependence.
|- Scientific Title||Impulsivity, a treatable risk factor in the onset and relapse to substance use disorders:
A randomized, double-blind, placebo-controlled trial of modafinil for alcohol dependence.
|- ACRONYM||TrIP - RCT|
|- hypothesis||It is expected that modafinil improves cognitive functioning in abstinent alcohol dependent patients, increases time to first relapse and reduces relapse rates and relapse severity. In addition, it is expected that participants with different genotypes will be affected differently by modafinil.|
|- Healt Condition(s) or Problem(s) studied||Alcohol abuse, Addiction, Alcohol|
|- 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;
4. Signed informed consent;
5. Following the behavioural treatment programme.
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-jan-2009|
|- planned closingdate||30-jun-2009|
|- Target number of participants||100|
|- Interventions||MODAFINIL GROUP: |
2. Single dose;
3. Oral administration;
4. (3 x 1 tablet of 100mg/day) during 10 weeks.
1. Day 1-5 : 100mg/day;
2. Day 6-10: 200mg/day;
3. Day 11-70: 300mg/day.
1. Placebo tablets, containing lactose (3 x 1 tablet);
2. Comparable administration and administration scheme as the modafinil group.
|- Primary outcome||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 outcome||Improvement or deterioration of specific characteristics (such as depression, ADHD symptoms, anhedonia, fatigue), due to the intervention of modafinil. |
|- Timepoints||Both neurocognitive and self-report questionnaires will be administered:|
1. Before treatment (= baseline measurement);
2. During treatment (after at least one week of a fixed dose of medication/placebo);
3. After treatment (= after 10 weeks of treatment AND testing at least one week after cessation of medication/placebo).
Follow-up: 3 and 6 months after cessation of treatment with modafinil.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Mrs Leen Joos |
|- CONTACT for SCIENTIFIC QUERIES||Mrs Leen Joos |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Institute for Addiction Research (AMC, AIAR), University of Antwerp, Collaborative Antwerp Psychiatric Research Institute (CAPRI), Psychiatric Centre Alexian Brothers (Boechout, Belgium)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||There is growing evidence that cognitive deficits play an important role in the development, course and relapse of substance abuse disorders. In particular, functions that involve control over one’s own behavior (impulsivity), and over behavior when confronted with motivationally relevant drug cues (craving) are related to relapse in recent studies. Because pharmacological manipulations of cognitive deficits are rare and relapses after treatment are the rule rather than the exception, we will present a randomized, double-blind, placebo-controlled trial with modafinil, a known cognitive enhancer and wake-promoting agent. Hundred alcohol dependent patients will be randomized to a single morning dose of modafinil (300mg/d), or matching placebo, for 10 weeks. Both neurocognitive tests (on impulsivity and overall cognitive functioning) and self-report questionnaires will be administered before, during and after treatment. Patients will be followed up 6 months after treatment, to measure relapse rate. Primary outcome variables are test performance, craving ratings and relapse. It is expected that modafinil improves cognitive functioning, increases time to first relapse and reduces relapse rates and relapse severity. In addition, DNA samples will be taken to investigate different polymorphisms associated with addiction and impulsivity. It is expected that participants with different genotypes will be affected differently by modafinil.|
|- Main changes (audit trail)|
|- RECORD||25-mrt-2009 - 9-mei-2012|