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Effect of N-acetylcysteine treatment on brain glutamate concentrations in nicotine dependence: A double-blind placebo controlled study.


- candidate number13234
- NTR NumberNTR3576
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2012
- Secondary IDs2011-EXT-1980 UvA faculty ethics committee
- Public TitleEffect of N-acetylcysteine treatment on brain glutamate concentrations in nicotine dependence: A double-blind placebo controlled study.
- Scientific TitleEffect of N-acetylcysteine treatment on brain glutamate concentrations in nicotine dependence: A double-blind placebo controlled study.
- ACRONYMNAC smoking dependence
- hypothesisA 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) studiedNicotine dependence
- Inclusion criteria1. Men;
2. 25-55 years old;
3. Smoking at least 15 cigarettes a day.
- Exclusion criteria1. Major illnesses;
2. Dependent on any other substance other than nicotine;
3. Currently on medication;
4. Ulcers;
5. Color blind.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-jun-2013
- Target number of participants50
- Interventions14 day administration of n-acetylcysteine (2400mg/d). The control group will receive a placebo.
- Primary outcome1. Glutamate concentrations in dACC and striatum;
2. Self-reported craving;
3. Self-reported withdrawal symptoms;
4. Neurocognitive tasks.
- Secondary outcomeN/A
- Timepoints1. Baseline measures before treatment;
2. Intermediate measures after 1 week;
3. Post-treatment measures.
- Trial web siteN/A
- statusopen: 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
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRecent 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)
- RECORD14-aug-2012 - 3-sep-2012


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