Alcohol Use DisordersLeADNCT01679145
Learning and Relapse Risk in Alcohol Dependence
An observational study of Alcohol Use Disorders, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
The aim of this project is to assess which behavioral and neuroimaging alterations associated with reward- based learning predict relapse in alcohol- dependent patients within a follow- up period of 12 months. 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 Disorders
- How many people
- 225 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2012to Mar 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Detoxified alcohol- dependent patients and age- and gender matched healthy controls living in Germany
Who may be able to join
- Alcohol dependence according to DSM-IV
- Minimum of 72 hours of abstinence, maximum of 21 days of abstinence
- Minimum of three years of alcohol dependence
- Low severity of withdrawal symptoms
- Ability to provide fully informed consent and to use self- rating scales
Who cannot join
- Lifetime history of DSM- IV bipolar or psychotic disorder
- Current threshold DSM-IV diagnosis of any following disorders: current major - depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder or obsessive- compulsive disorder
- History of substance dependence other than alcohol or nicotine dependence
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Technische Universität Dresden
Dresden, Saxony, 01187
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, 01307
About this study
Official title: Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients
The aim of this project is to assess which behavioral and neuroimaging alterations associated with reward- based learning predict relapse in alcohol- dependent patients within a follow- up period of 12 months.
The investigators will explore how these alterations interact with clinical and psychosocial factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to identify neurofunctional abnormalities in neurotransmitter systems. The investigators will also provide data for genetic analysis and modeling.
Read more
Patients will be detoxified in an inpatient setting and followed for 12 months using the Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and brain imaging will be carried out within at least 4 half- lives after any psychotropic medication.
The investigators will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters of learning with alcohol craving, intake and prospective relapse risk.
Read the detailed description
This project will examine 150 detoxified alcohol-dependent patients and 100 age- and gender matched controls. The main aim of this project is to assess 1) which behavioural and neuroimaging alterations (fMRI) associated with reward-based learning (see Projects 1 \& 3) predict relapse within the follow-up period of 6 months, 2) how these interact with clinical and psychosocial factors which can modify the relapse risk, and 3) to provide data for genetic and imaging analyses and modelling. Furthermore, we will explore gender effects on functional imaging parameters of learning. Patients will be detoxified in an inpatient setting and followed for 6 months using the Form 90 and Time-Line Follow-Back Procedure. Clinical assessments, behavioral paradigms of learning, and brain imaging will be carried out within at least 4 half-lives after any psychotropic medication. Subjects will undergo medical management with bimonthly follow-ups and predefined in- and exclusion criteria as described previously. We will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning as described in Projects 1 and 3. We will associate model parameters of learning with alcohol craving, intake and prospective relapse risk. Independent of these central questions, we will also assess comorbidity, psychosocial and neurobiological disease severity markers to control for specificity of findings.
- Conditions
- Alcohol Use Disorders
- Keywords
- Reward- based learning, Pavlovian-to-instrumental transfer, Functional imaging, Relapse risk
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol- dependent patients | Detoxified alcohol- dependent patients in an inpatient setting | |
| Control group | Age- and gender matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood oxygenation level dependent (BOLD) response
investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging
Measured: first assessment time point (alc. dependent pat. up to 21 days after detoxification)
Secondary outcomes (1)
Treatment response
test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients
Measured: 12-month follow-up period beginning after first assessment timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Hospital Carl Gustav Carus
- Responsible party
- Sponsor
- Investigators
- Andreas Heinz, Prof MD, Principal investigator, Charite University, Berlin, GermanyUlrich S Zimmermann, MD, Principal investigator, University Hospital Carl Gustav Carus, Dresden, GermanyAndreas Heinz, Prof MD, Study chair, Charité University, Berlin, GermanyHans-Ulrich Wittchen, Prof PhD, Study director, Technische Universität Dresden, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679145
- Sponsor's protocol ID
- HE2597/141;ZI1119/31;WI709/101
- Acronym
- LeAD
- Status last verified
- Jul 2016
- First submitted
- 31 Aug 2012
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Spitta G, Fliedner LE, Gleich T, Zindler T, Sebold M, Buchert R, Heinz A, Gallinat J, Friedel E. Association between DRD2/ANKK1 TaqIA Allele Status and Striatal Dopamine D2/3 Receptor Availability in Alcohol Use Disorder. J Integr Neurosci. 2022 Oct 28;21(6):171. doi: 10.31083/j.jin2106171.
PubMed 36424756Zindler 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 36001430Sebold M, Spitta G, Gleich T, Dembler-Stamm T, Butler O, Zacharias K, Aydin S, Garbusow M, Rapp M, Schubert F, Buchert R, Gallinat J, Heinz A. Stressful life events are associated with striatal dopamine receptor availability in alcohol dependence. J Neural Transm (Vienna). 2019 Sep;126(9):1127-1134. doi: 10.1007/s00702-019-01985-2. Epub 2019 Feb 12.
PubMed 30747311Schad DJ, Garbusow M, Friedel E, Sommer C, Sebold M, Hagele C, Bernhardt N, Nebe S, Kuitunen-Paul S, Liu S, Eichmann U, Beck A, Wittchen HU, Walter H, Sterzer P, Zimmermann US, Smolka MN, Schlagenhauf F, Huys QJM, Heinz A, Rapp MA. Neural correlates of instrumental responding in the context of alcohol-related cues index disorder severity and relapse risk. Eur Arch Psychiatry Clin Neurosci. 2019 Apr;269(3):295-308. doi: 10.1007/s00406-017-0860-4. Epub 2018 Jan 8.
PubMed 29313106
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients
- ClinicalTrials.gov ID
- NCT01679145
- Acronym / sponsor ID
- LeAD / HE2597/141;ZI1119/31;WI709/101
- Conditions
- Alcohol Use Disorders
- Keywords
- Reward- based learning, Pavlovian-to-instrumental transfer, Functional imaging, Relapse risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University Hospital Carl Gustav Carus
- Study start
- Jan 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to assess which behavioral and neuroimaging alterations associated with reward- based learning predict relapse in alcohol- dependent patients within a follow- up period of 12 months.
The investigators will explore how these alterations interact with clinical and psychosocial factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to identify neurofunctional abnormalities in neurotransmitter systems. The investigators will also provide data for genetic analysis and modeling.
Patients will be detoxified in an inpatient setting and followed for 12 months using the Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and brain imaging will be carried out within at least 4 half- lives after any psychotropic medication.
The investigators will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters of learning with alcohol craving, intake and prospective relapse risk.
Detailed description
This project will examine 150 detoxified alcohol-dependent patients and 100 age- and gender matched controls. The main aim of this project is to assess 1) which behavioural and neuroimaging alterations (fMRI) associated with reward-based learning (see Projects 1 \& 3) predict relapse within the follow-up period of 6 months, 2) how these interact with clinical and psychosocial factors which can modify the relapse risk, and 3) to provide data for genetic and imaging analyses and modelling. Furthermore, we will explore gender effects on functional imaging parameters of learning. Patients will be detoxified in an inpatient setting and followed for 6 months using the Form 90 and Time-Line Follow-Back Procedure. Clinical assessments, behavioral paradigms of learning, and brain imaging will be carried out within at least 4 half-lives after any psychotropic medication. Subjects will undergo medical management with bimonthly follow-ups and predefined in- and exclusion criteria as described previously. We will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning as described in Projects 1 and 3. We will associate model parameters of learning with alcohol craving, intake and prospective relapse risk. Independent of these central questions, we will also assess comorbidity, psychosocial and neurobiological disease severity markers to control for specificity of findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol- dependent patients | – | –Detoxified alcohol- dependent patients in an inpatient setting |
| Control group | – | –Age- and gender matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Detoxified alcohol- dependent patients and age- and gender matched healthy controls living in Germany
Key inclusion criteria (5 listed)
- Alcohol dependence according to DSM-IV
- Minimum of 72 hours of abstinence, maximum of 21 days of abstinence
- Minimum of three years of alcohol dependence
- Low severity of withdrawal symptoms
- Ability to provide fully informed consent and to use self- rating scales
Key exclusion criteria (3 listed)
- Lifetime history of DSM- IV bipolar or psychotic disorder
- Current threshold DSM-IV diagnosis of any following disorders: current major - depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder or obsessive- compulsive disorder
- History of substance dependence other than alcohol or nicotine dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood oxygenation level dependent (BOLD) response
Time frame: first assessment time point (alc. dependent pat. up to 21 days after detoxification)
investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging
1 secondary outcome
Treatment response
Time frame: 12-month follow-up period beginning after first assessment timepoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Derived from this study: PubMed 36424756Spitta G, Fliedner LE, Gleich T, Zindler T, Sebold M, Buchert R, Heinz A, Gallinat J, Friedel E. Association between DRD2/ANKK1 TaqIA Allele Status and Striatal Dopamine D2/3 Receptor Availability in Alcohol Use Disorder. J Integr Neurosci. 2022 Oct 28;21(6):171. doi: 10.31083/j.jin2106171.
- Derived from this study: PubMed 36001430Zindler 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.
- Derived from this study: PubMed 30747311Sebold M, Spitta G, Gleich T, Dembler-Stamm T, Butler O, Zacharias K, Aydin S, Garbusow M, Rapp M, Schubert F, Buchert R, Gallinat J, Heinz A. Stressful life events are associated with striatal dopamine receptor availability in alcohol dependence. J Neural Transm (Vienna). 2019 Sep;126(9):1127-1134. doi: 10.1007/s00702-019-01985-2. Epub 2019 Feb 12.
- Derived from this study: PubMed 29313106Schad DJ, Garbusow M, Friedel E, Sommer C, Sebold M, Hagele C, Bernhardt N, Nebe S, Kuitunen-Paul S, Liu S, Eichmann U, Beck A, Wittchen HU, Walter H, Sterzer P, Zimmermann US, Smolka MN, Schlagenhauf F, Huys QJM, Heinz A, Rapp MA. Neural correlates of instrumental responding in the context of alcohol-related cues index disorder severity and relapse risk. Eur Arch Psychiatry Clin Neurosci. 2019 Apr;269(3):295-308. doi: 10.1007/s00406-017-0860-4. Epub 2018 Jan 8.
- English study descriptionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Heinz, Prof MD principal investigator
Charite University, Berlin, Germany
Ulrich S Zimmermann, MD principal investigator
University Hospital Carl Gustav Carus, Dresden, Germany
Andreas Heinz, Prof MD study chair
Charité University, Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorders, 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 5 inclusion and 3 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 28 Jul 2016. 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. 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?
blood oxygenation level dependent (BOLD) response (time frame: first assessment time point (alc. dependent pat. up to 21 days after detoxification)). 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 NCT01679145, which also lists 4 linked publications.
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 28 Jul 2016.