Alcohol Use Disorder Clinical Trial
— LeAD_FP2Official title:
Learning and Decision Making as Predictors of Treatment Outcome in Alcohol Use Disorder (Funding Period 2)
Verified date | July 2020 |
Source | Technische Universität Dresden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will examine clinical alterations in learning and automated approach
behaviour and their neurobiological correlates in alcohol-dependent patients and healthy
social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT;
randomized "verum" versus "placebo" training) which trains subjects to habitually push
alcohol pictures away.
The investigators will test whether activations following treatment predict relapse rate
(primary outcome measure) and the prospective amount of alcohol intake (secondary outcome
measure) within a six-month follow-up period.
Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm
established during the first funding period to distinguish the effects of appetitive,
aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and to
assess ZJT training effects comparing functional activation before and after ZJT training.
The investigators will also scan subjects during performance of a short standard working
memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based
Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its
effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).
Status | Completed |
Enrollment | 258 |
Est. completion date | June 2020 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Men and women aged 18-65 years - alcohol dependence/alcohol use disorder according to ICD-10 and alcohol-use disorder according to DSM-5 - Minimum of 72 hours of abstinence, maximum of 21 days of abstinence - Minimum of three years with alcohol dependence/alcohol use disorder - Low severity of withdrawal symptoms - Ability to provide fully informed consent and to use self-rating scales - Sufficient understanding of the German language Exclusion Criteria: - Lifetime history of DSM-IV bipolar, psychotic disorder, or substance dependence other than nicotine dependence. Patients may have had lifetime alcohol dependence/alcohol use disorder diagnoses. - Current threshold DSM-IV diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder - History of substance dependence other than alcohol or nicotine dependence - Current substance use other than nicotine and alcohol as evinced by positive urine test - History of severe head trauma or other severe central neurological disorder (dementia, Parkinson's disease, multiple sclerosis) - Pregnancy or nursing infants - Any alcohol intake within the last 24 hours - Use of medications or drugs known to interact with the central nervous system within the last 10 days, except detoxification treatment with benzodiazepines or clomethiazole, with testing at least four half-lives post last intake |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Technische Universität Dresden | Dresden | |
Germany | Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden | Dresden | Saxony |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | Charite University, Berlin, Germany, University Hospital Carl Gustav Carus |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relapse to heavy drinking | defined as the consumption of over 60g of alcohol per occasion in men and of over 40g of alcohol in women | 6 months | |
Secondary | amount of alcohol intake during the follow-up period | Timeline Followback interview for each day during the follow-up period | 6 months | |
Secondary | blood oxygenation level-dependent (BOLD) signal | at assessment and after last training (approx. 2 weeks after assessment) |
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