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Stages in addiction


- candidate number21600
- NTR NumberNTR5049
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2015
- Secondary IDsNL51301.018.14 
- Public TitleStages in addiction
- Scientific TitleStages in addiction: a functional magnetic resonance imaging (fMRI) study into the neural mechanisms of chronic and non-chronic alcohol dependence and gambling disorder
- ACRONYM
- hypothesisThe main aim of the proposal is to study the processes involved in non-chronic vs. chronic drug seeking behavior in samples of alcohol dependent persons (ADs) and pathological gamblers (PGs) with different levels of chronicity. We thereby rely on knowledge derived from animal work and implement tests of impulsivity, compulsivity, goal-directed and habitual behavior and positive and negative reinforcement.
- Healt Condition(s) or Problem(s) studiedAddiction, Alcohol dependence, Gambling addiction
- Inclusion criteriaInclusion process: Potential participants are informed about the study and receive an information letter. After this, they are contacted by telephone. If interested to participate, screening for inclusion and exclusion criteria is performed, using structured diagnostic interviews, e.g. Composite International Diagnostic Interview (World Health Organisation, 1997). Relevant sections are included: demographics; alcohol use disorders; substance use disorders; depressive disorders and mania; psychotic disorders and post-traumatic stress disorder. The following sections are included from the Diagnostic Interview Schedule (DIS, Robins, 1981): pathological gambling; antisocial personality disorder.

AD group:
Chronic group
- Recent DSM-V diagnosis of AD (<4 months past detoxification).
- Currently in treatment for AD (>3 weeks past detoxification)
- Seeking treatment for at least the third time lifetime and a minimum illness duration of 7 years (chronic addiction). Non-chronic group
- Recent DSM-V diagnosis of AD (<4 months past detoxification).
- Currently in treatment for AD (>3 weeks past detoxification)
- Seeking treatment for the first time and with a maximum illness duration of 2 years (non-chronic addiction).

PG group:
Chronic group
- Recent DSM-V diagnosis of PG (active gambling <3 months ago).
- Seeking treatment for at least the third time lifetime and a minimum illness duration of 7 years (chronic addiction).
Non-chronic group
- Recent DSM-V diagnosis of PG (active gambling <3 months ago).
- Seeking treatment for the first time and with a maximum illness duration of 2 years (non-chronic addiction).

HC group:
- No diagnosis (current or history) of AD or PG.
- Exclusion criteriaCurrent major depressive disorder, bipolar disorder, psychotic disorder, alcohol or substance dependence, or any cognitive disorder as assessed with the MINI neurological disorders section
IQ below 80
insufficient command of the Dutch language
MRI contraindications such as metal implants, claustrophobia, left-handedness, pregnancy
recent (<2 weeks) use of psychotropic medication other than naltrexone (smoking and nicotine dependence is allowed in all groups).
Endocrinological disorders or regular use of corticosteroids
Current treatment with tricyclic antidepressant or antipsychotic medication
Use of other psychotropic medication (apart from SSRI's), or of recreational drugs over a period of 72 hours prior to each test session, and use of alcohol within the last 24 hours before each measurement
Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline travel).

PG group and HC group:
more than 21 alcoholic drinks/week for men and more than 15 drinks/week for women, history of AD
PG group:
any other current substance dependence than PG.
AD group:
current substance dependence other than AD.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-jan-2018
- Target number of participants125
- InterventionsNone
- Primary outcome Balance between goal-directed and habitual responding as determined by the habit task
Interaction between response inhibition and salience attribution as determined by the affective Go/NoGo task
The effect of affective stimuli on working memory performance as determined by the affective working memory task
Brain activation as measured with fMRI (Blood Oxygen Level Dependent or BOLD responses) during the habit task, the affective Go/NoGo task and the affective working memory task
Connectivity between brain areas: DLPFC-limbic reward circuitry, DLPFC-basal ganglia connectivity, during performance of a cognitive flexibility task and during performance of a cue-reactivity reduction task.
Baseline fMRI measures, and connectivity after rTMS in an fMRI session in comparison to connectivity during baseline (within subjects comparison). Differences in brain connectivity between non-chronic and chronic alcohol dependence group and pathological gambling group, and healthy control group.
- Secondary outcome Alcohol use severity as measured by the Alcohol Use Diagnostic Interview Test (AUDIT) [19] and the alcohol abstinence self-efficacy scale [20]
Gambling severity as measured by the Canadian Problem Gambling Index (CPGI) questionnaire [21]
Depressive and anxiety symptoms as measured by respectively the 21 item version of the Beck Depression Inventory (BDI) [22], the State version of the state-trait anxiety inventory (STAI) [23]
Impulsivity as measured by the Barratt Impulsivity Screening (BIS-11) [24]), the Behavioral Inhibition and Behavioral Activation Scales (BIS/BAS) [25], the UPPS Impulsive Behavior Scale [26] and compulsivity measures.
Executive functioning as measured by a number of CANTAB tasks (see section 5.4 Self report measures).
- TimepointsN/A
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. Tim van Timmeren
- CONTACT for SCIENTIFIC QUERIESdrs. Tim van Timmeren
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organisation for Scientific Research (NWO)
- Publications
- Brief summaryThe main aim of the proposal is to study the processes involved in non-chronic vs. chronic drug seeking behavior in samples of alcohol dependent persons (ADs) and pathological gamblers (PGs) with different levels of chronicity. We thereby rely on knowledge derived from animal work and implement tests of impulsivity, compulsivity, goal-directed and habitual behavior and positive and negative reinforcement.
- Main changes (audit trail)
- RECORD21-jan-2015 - 18-apr-2015


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