Learning and Relapse Risk in Alcohol Dependence (FP2)

NCT02615977 | Completed

• 1 other identifier: HE2597/142;ZI1119/32;WI709/102
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Alcohol Use Disorder

Keywords

Pavlovian conditioning, Operant conditioning; Pavlovian-to-instrumental transfer; Functional imaging; Relapse risk; Behavioural Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• amount of alcohol intake during the follow-up period

  6 months

• blood oxygenation level-dependent (BOLD) signal

  at assessment and after last training (approx. 2 weeks after assessment)

Study Arms (2)

Intervention

EXPERIMENTAL

In the "verum treatment condition", i.e. Zooming Joystick Task, 90% of all alcohol-related pictures appear in the landscape format and hence are trained to be pushed away.

Behavioral: Zooming Joystick Task

Placebo Intervention

PLACEBO COMPARATOR

In the placebo condition, i.e. Zooming Joystick Task (Placebo), alcohol picture are as often pushed away as pulled towards the subject.

Behavioral: Zooming Joystick Task (Placebo)

Interventions

Zooming Joystick Task BEHAVIORAL

Subjects are instructed to use the joystick to pull all pictures (alcoholic and non-alcoholic beverages) towards them that appear in the portrait format, while pictures in a landscape format are pushed away. Half of the pictures are alcohol-related and the other half is not. The assignment of stimuli (alcohol versus neutral) to the picture format (portrait versus landscape) is manipulated (see 'Study Arm' descriptions). Arousal and valence of the alcohol and non-alcohol pictures is rated as previously described. The investigators will apply six sessions of ZJT training, as this number has been proven sufficient for reducing relapse rates.

Also known as: Alcohol Approach Avoidance Task

Intervention

Zooming Joystick Task (Placebo) BEHAVIORAL

Subjects are instructed to use the joystick to pull all pictures (alcoholic and non-alcoholic beverages) towards them that appear in the portrait format, while pictures in a landscape format are pushed away. Half of the pictures are alcohol-related and the other half is not. The assignment of stimuli (alcohol versus neutral) to the picture format (portrait versus landscape) is manipulated (see 'Study Arm' descriptions). Arousal and valence of the alcohol and non-alcohol pictures is rated as previously described. The investigators will apply six sessions of ZJT training, as this number has been proven sufficient for reducing relapse rates.

Also known as: Alcohol Approach Avoidance Task (Placebo)

Placebo Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Charite University, Berlin, Germany: collaborator
• University Hospital Carl Gustav Carus: collaborator

Study Sites (3)

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Dresden, Saxony, 01307, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Technische Universität Dresden

Dresden, 01187, Germany

Location

Related Publications (1)

• Zindler T, Frieling H, Fliedner L, Veer IM, Neyazi A, Awasthi S, Ripke S, Walter H, Friedel E. How alcohol makes the epigenetic clock tick faster and the clock reversing effect of abstinence. Addict Biol. 2022 Sep;27(5):e13198. doi: 10.1111/adb.13198.

  PMID: 36001430 DERIVED

Related Links

• English study description

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Andreas Heinz, Prof PhD MD

  Charite University, Berlin, Germany

  STUDY CHAIR

• Hans-Ulrich Wittchen, Prof PhD

  Technische Universität Dresden, Dresden, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 26, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

DE (3)