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ID
Source
Brief title
Health condition
nicotine dependence
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Self-reported craving;
2. Self-reported withdrawal symptoms;
3. Neurocognitive tasks.
Secondary outcome
N/A
Background summary
Preclinical 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.
Study objective
A 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.
Study design
1. 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.
Intervention
1. 4 day administration of 3600 mg of N-acetylcysteine;
2. 4 day administration of placebo.
Inclusion criteria
1. Undergraduate students;
2. Smoking minimum of 15 sigarettes a day.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL2086 |
| NTR-old | NTR2204 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |