|- candidate number||13234|
|- NTR Number||NTR3576|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-aug-2012|
|- Secondary IDs||2011-EXT-1980 UvA faculty ethics committee|
|- Public Title||Effect of N-acetylcysteine treatment on brain glutamate concentrations in nicotine dependence: A double-blind placebo controlled study.|
|- Scientific Title||Effect of N-acetylcysteine treatment on brain glutamate concentrations in nicotine dependence: A double-blind placebo controlled study.|
|- ACRONYM||NAC smoking dependence|
|- hypothesis||A two-week daily treatment with NAC (2400 mg/d) will change glutamate concentrations in the dACC and striatum in nicotine dependent subjects, while no effect of placebo on glutamate concentrations is expected. Treatment with NAC will show positive effects on clinical outcome and will reduce impulsivity, while placebo is expected to have no effect on these measures. A positive relationship between glutamate changes, impulsivity and clinical outcome measures is expected.|
|- Healt Condition(s) or Problem(s) studied||Nicotine dependence|
|- Inclusion criteria||1. Men;|
2. 25-55 years old;
3. Smoking at least 15 cigarettes a day.
|- Exclusion criteria||1. Major illnesses;|
2. Dependent on any other substance other than nicotine;
3. Currently on medication;
5. Color blind.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-jun-2013|
|- Target number of participants||50|
|- Interventions||14 day administration of n-acetylcysteine (2400mg/d). The control group will receive a placebo.|
|- Primary outcome||1. Glutamate concentrations in dACC and striatum;|
2. Self-reported craving;
3. Self-reported withdrawal symptoms;
4. Neurocognitive tasks.
|- Secondary outcome||N/A|
|- Timepoints||1. Baseline measures before treatment;|
2. Intermediate measures after 1 week;
3. Post-treatment measures.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Mieke Mors-Schulte, ter|
|- CONTACT for SCIENTIFIC QUERIES|| Mieke Mors-Schulte, ter|
|- Sponsor/Initiator ||Academic Medical Center (AMC, Amsterdam)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Recent literature has highlighted the importance of the excitatory amino acid glutamate in drug addiction, especially its role in the continuation of and relapse into substance abuse. The study investigates the effect of NAC treatment on clinical and neurocognitive outcomes, but also the effect on glutamate concentrations in different brain structures in nicotine dependency. To this end, 50 nicotine dependent subjects will receive a two week treatment or placebo. During pre- and post-treatment sessions, assessments consist of several questionnaires, neurocognitive measurements, and magnetic resonance spectroscopy (MRS).
Country of recruitment = the Netherlands.
|- Main changes (audit trail)|
|- RECORD||14-aug-2012 - 3-sep-2012|