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Alcohol Use DisorderLeAD_FP2NCT02615977

Learning and Relapse Risk in Alcohol Dependence (FP2)

A study testing Zooming Joystick Task in people with Alcohol Use Disorder, run by Technische Universität Dresden at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Zooming Joystick Task
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
3 sitesGermany
Study dates
Apr 2015to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

    Dresden, Saxony, 01307

  • Technische Universität Dresden

    Dresden, 01187

Other trials in Germany

About this study

Official title: Learning and Decision Making as Predictors of Treatment Outcome in Alcohol Use Disorder (Funding Period 2)

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.

Read more

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).

Read the detailed description

This Project will examine 130 detoxified alcohol-dependent patients and 40 age- and gender matched controls. All subjects will be treated with Zooming Joystick Task (ZJT) training to alter a habitual alcohol cue approach bias. The primary aim of this project is to assess

  1. which behavioural and neuroimaging alterations (fMRI) associated with reward-based learning are altered by ZJT treatment and which alterations predict treatment outcome (primary outcome: relapse, secondary outcome: amount of alcohol intake) within the follow-up period of 6 months,
  2. how these alterations interact with clinical and psychosocial factors that can modify relapse risk, and
  3. to provide data for genetic and imaging analyses and modelling. Furthermore, the investigators will explore gender effects on functional imaging parameters of learning.

Patients will be detoxified in an inpatient setting, receive six sessions of the ZJT in a randomized placebo controlled design and will be followed for six months using the Time-Line Follow-Back Procedure. Clinical assessments, behavioural paradigms of learning, and brain imaging will be carried out within at least four half-lives after any psychotropic medication. Subjects will undergo medical management with biweekly follow-ups and predefined inclusion and exclusion criteria as previously described. Functional imaging paradigms will be applied, assessing

  1. Pavlovian-to-instrumental transfer,
  2. habitual versus goal directed behaviour and
  3. working memory.

The investigators will associate model parameters of learning with functional activation and prospective intake controlling for comorbidity, psychosocial and neurobiological disease severity markers.

Being tested
Zooming Joystick Task, Zooming Joystick Task (Placebo)
Keywords
Pavlovian conditioning, Operant conditioning, Pavlovian-to-instrumental transfer, Functional imaging, Relapse risk, Behavioural Intervention
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zooming Joystick TaskBehavioural

    Also called Alcohol Approach Avoidance Task

    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.

  • Zooming Joystick Task (Placebo)Behavioural

    Also called Alcohol Approach Avoidance Task (Placebo)

    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.

Study groups in NCT02615977
Study groupRoleWhat they receive
InterventionExperimentalIn 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.
Receives: Behavioral: Zooming Joystick Task
Placebo InterventionPlacebo comparatorIn the placebo condition, i.e. Zooming Joystick Task (Placebo), alcohol picture are as often pushed away as pulled towards the subject.
Receives: Behavioral: Zooming Joystick Task (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (2)

  1. amount of alcohol intake during the follow-up period

    Timeline Followback interview for each day during the follow-up period

    Measured: 6 months

  2. blood oxygenation level-dependent (BOLD) signal

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2018
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615977
Sponsor's protocol ID
HE2597/142;ZI1119/32;WI709/102
Acronym
LeAD_FP2
Status last verified
Jul 2020
First submitted
20 Nov 2015
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36001430

Questions about this trial

What is this clinical trial studying?

A study testing Zooming Joystick Task in people with Alcohol Use Disorder, run by Technische Universität Dresden at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

relapse to heavy drinking (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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