Aim: This research will look at the implicit and explicit drug-related cognitions, at the effect of marketing cues on brain activity, and at the effect on aggressive behaviour, in alcohol users, cannabis users, and a control group. These effects…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief en emotioneel functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter: the implicit association cannabis and alcohol users have
with marketing cues of their drug, as measured with the Single Category
Implicit Association task (SC-IAT).
Secondary outcome
Secondary study parameters:
Activation of the reward neurocircuitry in the brain as measured with the BOLD
response in the fMRI -scanner.
Aggressive behaviour as measured with the point-to-subtraction task and
aggression SC-IAT.
Background summary
Rationale: First, drug-related cognitions have been implicated in the aetiology
and maintenance of drug abuse. Second, research has shown that marketing has a
significant effect on the consuming patterns of alcohol and tobacco users.
Third, a relation between drug use and aggressive behaviour is often suggested.
Study objective
Aim: This research will look at the implicit and explicit drug-related
cognitions, at the effect of marketing cues on brain activity, and at the
effect on aggressive behaviour, in alcohol users, cannabis users, and a control
group. These effects will be investigated during abstinence as well as during
intoxication in the alcohol and cannabis group. Subjects from the control group
will not receive a treatment.
Study design
Study Design: double blind, placebo controlled, mixed design.
Intervention
Alcohol users will receive single doses of alcohol and placebo; cannabis users
will receive single doses of cannabis and placebo; the control group will not
receive any treatment.
Study burden and risks
Total amount of invested time for each subject is about 16 hours (8 for control
subjects). A medical screening will take place, inlcuding an electrocardiogram
(ECG), urine and blood analyses. Each testday will last about 6 hours. Subjects
have to meake sure to get a good nights rest before each test day. Also they
are not allowed to use cafeine of alcohol 24 hours prior to each testday.
Cannabis users are not allowed to use cannabis 5 days prior to each test day.
universiteitssingel 40
Maastricht 6229 ER
NL
universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Regular alcohol users: as using on average 21 to 50 alcoholic drinks/week for males or 15 to 35 alcoholic drinks/week for females during the last year, drinking alcohol both during the week as during the weekend ;- Regular cannabis users: having used cannabis at least 3 times a week but no more than 10 times a week, during the previous year. ;- Controls not currently using cannabis, experimental use of cannabis is allowed if it is more than a year ago and not more than 5 times in total. Alcohol use should be between 1 and 14 consumptions a week for men, and between 1 and 7 for women.;For all groups:;Age between 18 and 40 years;Free from psychotropic medication;Good physical health as determined by medical examination and laboratory analysis;Absence of any major medical, endocrine and neurological condition;Normal weight, body mass index (weight/height2) between 18.5 and 28 kg/m2;Written Informed Consent
Exclusion criteria
History of drug abuse (other than the use of cannabis for the cannabis group and alcohol for the alcohol group) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination);Pregnancy or lactation;Hypertension (diastolic> 90; systolic> 140);Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination);Liver dysfunctioning;(Serious) side effects to previous cannabis or alcohol use;History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*);For women: no use of a reliable contraceptive
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-001516-29-NL |
| CCMO | NL40475.068.12 |