The current protocol aims to test the effects of intervals between subsequent startle measurements on the sensitivity of FPS to alcohol.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The magnitude of fear-potentiated startle (FPS).
Secondary outcome
Subjective measures of anxiety (questionnaires).
Background summary
Human experimental models based on Fear-Potentiated Startle (FPS) are extremely
sensitive to manipulations of fear and anxiety an for individual differences in
trait anxiety. These models have also been studied extensively for their
sensitivity to anxiolytic properties of drugs. There have been some conflicting
findings with benzodiazepines, and the aim of this study is to vary a parameter
that may affect the sensitivity of the FPS model to the anxiety-reducing
properties of GABA-ergic substances.
In previous studies the effect of GABAergic compounds have been observed when
the intervals between subsequent startle measurements were long (on average >
20 s; Curtin et al., 1998, 2001; Graham et al., 2005; Grillon et al., 2006;
Moberg et al., 2009; Riba et al., 2001), but not when they were short (on
average < 20 s; Baas et al., 2002, 2009). Alcohol has comparable effects on FPS
as benzodiazepines (Moberg et al., 2009). The current protocol aims to test the
effects of intervals between subsequent startle measurements on the sensitivity
of FPS to alcohol.
For this purpose, one dosage of alcohol (based on Moberg et al.: 0.08% BAC) is
compared to placebo.
Study objective
The current protocol aims to test the effects of intervals between subsequent
startle measurements on the sensitivity of FPS to alcohol.
Study design
In the pilot study the version of the FPS model with short and long intervals
are compared directly against each other in a cross-over design. In the alcohol
study, the short versus long versions are both tested once with a dose of
alcohol and once with placebo are tested in 4 test days.
Intervention
Anxiety is induced by means of threat of shock. This is repeated in the alcohol
study with a dose of alcohol compared to placebo.
Study burden and risks
The burden on the subjects is during maximally 6 weeks 4 times a testday of
1-1.5 hours. The anxiety induction and the physiological measurements involved
has been done by hundreds of participants without serious consequences. The
dose of alcohol given during the alcohol study is a little but not much higher
than what the group of social drinkers among which we recruit our participants
is used to in their daily life.
Because the development of good models for testing anxiolytic drugs is
important, we assess that these goals outweigh the relatively small burden and
relatively minor risks.
Heidelberglaan 2
3584 CS Utrecht
NL
Heidelberglaan 2
3584 CS Utrecht
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36112.041.11 |