Magnitude of contextual startle potentiation as a function of inter startle interval: A pilot study and a cross-over alcohol design

Magnitude of contextual startle potentiation as a function of inter startle interval: A pilot study and a cross-over alcohol design - Contextual startle potentiation and inter startle interval

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35832

Enrollment

Registered

2011-12-13

Start date

2011-04-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorder

Interventions

Anxiety is induced by means of threat of shock. This is repeated in the alcohol study with a dose of alcohol compared to placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * He/she is aged between 21-50 (in the pilot study, since there is no alcohol administration involved, a minimum age of 18 is sufficient) * Written informed consent (see appendix E2) * Normal static binocular acuity, corrected or uncorrected * Normal hearing * BMI within the normal range (19-30) (alcohol study only) * For women, adequate birth control medication is required (alcohol study only) * Social Drinker (average of 7 to 21 alcoholic drinks per week) and recent experience with the dose of alcohol to be administered (dose is dependent on the weight and gender of the participant) (alcohol study only) * Be considered as reliable and mentally capable of adhering to the protocol

Exclusion criteria

Exclusion criteria: * Regular drug use in the past month prior to the first test session (during participation no drug use is allowed) * Pregnancy (alcohol study only) * Use of psychoactive medication (alcohol study: or medication that cannot be combined with alcohol use) from the last month prior to the first test session or during participation * Physical or mental illness * Excessive alcohol use (>21 alcoholic drinks per week) or a score indicating problematic alcohol use on the Alcohol Use Disorders Identification Task (AUDIT)* Excessive smoking (more than 10 cigarettes per day) * Intake of caffeine-containing beverages over 5 glasses per day * Small startle responses (a mean of less than 5 µV over nine startle responses) or no startle response on at least one trial of the baseline startle reactivity screening

Design outcomes

Primary

Measure	Time frame
The magnitude of fear-potentiated startle (FPS).	—

Secondary

Measure	Time frame
Subjective measures of anxiety (questionnaires).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)