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N-acetylcysteine in heavy smokers: A double-blind randomized controlled trial.


- candidate number7742
- NTR NumberNTR2204
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2010
- Secondary IDs 
- Public TitleN-acetylcysteine in heavy smokers: A double-blind randomized controlled trial.
- Scientific TitleN-acetylcysteine in heavy smokers: A double-blind randomized controlled trial.
- ACRONYMnicotine dependence N-Acetylcysteine
- hypothesisA four day adminstration of N-acetylcysteine (3600 mg/day) will reduce craving, withdrawal symptoms and the bias towards nicotine related cues compared to a four day administration of placebo in nicotine dependent subjects.
- Healt Condition(s) or Problem(s) studiedNicotine dependence
- Inclusion criteria1. Undergraduate students;
2. Smoking minimum of 15 sigarettes a day.
- Exclusion criteria1. Major illnesses;
2. Dependent on any other substance other than nicotine;
3. Currently on medication other than birth control;
4. Pregnant or planning to become pregnant;
5. Ulcers;
6. Color blind.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-nov-2010
- Target number of participants20
- Interventions1. 4 day administration of 3600 mg of N-acetylcysteine;
2. 4 day administration of placebo.
- Primary outcome1. Self-reported craving;
2. Self-reported withdrawal symptoms;
3. Neurocognitive tasks.
- Secondary outcomeN/A
- Timepoints1. First week: 4 days administration of either N-acetylcysteine or placebo;
2. Second week: Wash-out period;
3. Third week, cross-over: 4 days administration of either N-acetylcysteine or placebo.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD L. Schmaal
- CONTACT for SCIENTIFIC QUERIESPhD L. Schmaal
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryPreclinical studies and human pilot studies have shown reduced drug seeking behavior and craving in substance dependent rats and humans. In the current study, we will investigate whether a four day administration of N-acetylcysteine (3600 mg) will reduce craving and the bias towards nicotine related cues in heavy smokers. Twenty heavy smoking students (>15 sigarettes a day) are recruited for this double blind, randomised cross-over study. During the first week participants will receive either N-acetylcysteine or placebo during 4 days. After a week wash-out period, participants will cross-over to receive NAC or placebo during the last 4 days. During the testing periods, participants will report craving levels and withdrawal symptoms and perform neurocognitive tasks.
- Main changes (audit trail)
- RECORD8-feb-2010 - 17-feb-2010


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