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Systems neuropharmacology of nicotine in aversive learning in humans

Phase 4
Conditions
Healthy subjects
Registration Number
DRKS00025233
Lead Sponsor
Institut für Systemische Neurowissenschaften
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
88
Inclusion Criteria

healthy,
non-smoker,
18-40 years old,
normal BMI

Exclusion Criteria

1. past or present illnesses of the
- Brain or mind (incl. anxiety disorders, depression, schizophrenia, alcohol, drug or medication dependence, neurological disorders other than occasional headaches),
- Heart or circulatory system (incl. hypertension),
- blood,
- lung,
- liver,
- kidneys,
- thyroid gland,
- Eyes (including glaucoma, color blindness, and myopia greater than -5 diopters),
- skin,
- gastrointestinal tract,
- metabolism.
It does not matter whether the disease is treated or untreated, was long or short term, or dates back a long time. This does not include former childhood illnesses and former harmless illnesses such as common gastrointestinal infections, stress headaches, colds, etc.
2. cancer.
3. hypersensitivity to nicotine.
4. current medication and medication in a period of 2 months before treatment. Only over-the-counter medications are excluded if their intake dates back more than 1 week before participation in the study.
5. other serious health problems or current severe mental or physical stress.
6. having metallic objects in or on the body that cannot be removed.
7. cigarette consumption of less than 1 cigarette in lifetime (never-smoker).

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Group 1: The primary outcome measurement is the mean differential CS-response measured as US expectancy in the last block (8 trials) during ACQ (acquisition) compared to group 2 & 3 [(CS+ - CS-)ACQ,Block3,Group1<(CS+ - CS-)ACQ,Block3,Groups2&3]. <br>Group 2: The primary outcome measurement is the mean differential CS-response measured as US expectancy in the last block (8 trials) during EXT (extinction) compared to group 3 [(CS+ - CS-)EXT,Block2,Group2<(CS+ - CS-)EXT,Block2,Groups3].
Secondary Outcome Measures
NameTimeMethod
Group1: Secondary outcome measures are the mean differential CS-responses measured as Fear ratings, skin conductance and hemodynamic brain responses (see ROIs) in the last block (8 trials) during ACQ compared to group 2 & 3 [(CS+ - CS-)ACQ,Block3,Group1<(CS+ - CS-)ACQ,Block3,Groups2&3]. <br>Group2: Secondary outcome measures are the mean differential CS-responses measured as Fear ratings, skin conductance and hemodynamic brain responses (see ROIs) in the last block (8 trials) during EXT compared to group 3 [(CS+ - CS-)EXT,Block2,Group2<(CS+ - CS-)EXT,Block2,Groups3].
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