|- candidate number||12366|
|- NTR Number||NTR3428|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2012|
|- Secondary IDs|| |
|- Public Title||Drug addictions: Marketing and brain activity.|
|- Scientific Title||Drug addictions: Marketing and brain activity.|
|- ACRONYM||marketing and brain activity|
|- hypothesis||The present study will investigate:|
1. Whether drug-related cues activate the same neural networks as does the administration of the drug itself;
2. The implicit and explicit associations of alcohol and cannabis users;
3. The effect of acute doses of alcohol and cannabis on aggressive behaviour in alcohol and cannabis users.
This will be investigated in an alcohol and a cannabis users group while they are intoxicated and compared with a placebo condition and with a control group.
|- Healt Condition(s) or Problem(s) studied||Cognitive functioning|
|- Inclusion criteria||For alcohol users:|
1. 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;
2. Not currently using cannabis, experimental use of cannabis is allowed if it is more than a year ago.
1. Used between 3 and 10 times a week during the previous year;
2. Uses between 1 and 14 units of alcohol/week.
1. Not currently using cannabis, experimental use of cannabis is allowed if it is more than a year ago;
2. Incidental use of alcohol (between 1 and 14 units of alcohol/week).
1. Age between 18 and 40 years;
2. Free from psychotropic medication;
3. Good physical health as determined by medical examination and laboratory analysis;
4. Absence of any major medical, endocrine and neurological condition;
5. Normal weight, body mass index (weight/height2) between 18.5 and 28 kg/m2;
6. Written Informed Consent.
|- Exclusion criteria||1. 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);|
2. Pregnancy or lactation;
3. Hypertension (diastolic> 90; systolic> 140);
4. Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination);
5. Liver dysfunctioning;
6. (Serious) side effects to previous cannabis or alcohol use;
7. History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…);
8. For women: No use of a reliable contraceptive.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||31-dec-2013|
|- Target number of participants||60|
|- Interventions||Cannabis users will receive 300 µg/kg THC and placebo. Cannabis and placebo will be administered using a Volcano vaporizer, which will also ensure blinding.|
Alcohol users will receive alcohol and placebo. Alcohol (ethyl alcohol 96%) will be mixed with orange juice and will be adjusted for each subject in order to reach a BAC of 0,8 g/L. The placebo drink will consist of orange juice only. To ensure blinding, a couple of drops of alcohol will be put on the edge of the glass, so that subject smell the alcohol while drinking.
The control group will receive no treatment.
|- Primary outcome||Implicit associations of cannabis and alcohol users.|
|- Secondary outcome||Activation of the reward neurocircuitry in the brain and aggressive behavior.|
|- Timepoints||Measurements will take place around Tmax of cannabis and alcohol.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| E.L. Theunissen|
|- CONTACT for SCIENTIFIC QUERIES|| E.L. Theunissen|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.
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.
|- Main changes (audit trail)|
|- RECORD||10-mei-2012 - 19-mei-2012|