Alcohol DrinkingPhase 2/3SFB636D6NCT00926900
The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
A Phase 2/3 study testing D-cycloserine in people with Alcohol Drinking, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- D-cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Apr 2012
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current DSM-IV/ ICD-10 diagnosis of alcohol dependence
- controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care
- women (in childbearing age): use of a highly effective method of contraception
- normal or corrected-to-normal vision
- ability to provide written informed consent
Who cannot join
- diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence)
- positive drug screening
- current medication with anti-convulsive or psychotropic drugs
- MRI ineligibility
- sensitivity to study medication as evidenced by a history of adverse drug experience
- severe withdrawal symptoms (e.g. convulsions, delirium)
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- disposition towards experiencing convulsions/ epilepsy
- history of schizophrenic disorders/ affective psychosis
- neurological diseases that might affect the dopaminergic, limbic and frontal cortices or extrapyramidal motor functioning
- major diseases (e.g. diabetes, liver cirrhosis, heart disease)
- physical illness interfering with study procedures or affecting study outcomes
- pregnancy (positive test results)/ lactation period
- suicidal tendencies/ increased risk that others might be harmed -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Central Institute of Mental Health
Mannheim, 68159
Falk Kiefer, Professor, +49 621 1703 3522, falk.kiefer@zi-mannheim.de
Falk Kiefer, Professor
About this study
The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function.
It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity.
Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.
- Conditions
- Alcohol Drinking
- Being tested
- D-cycloserine, Placebo
- Keywords
- Alcoholism, D-cycloserine, extinction, cue-exposure
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
50 mg at approximately 1.5 hours prior to cue-exposure training sessions
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine | Active comparator | Not described Receives: Drug: D-cycloserine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
Measured: following completion of cue-exposure therapy
Secondary outcomes (1)
time to first severe relapse to alcohol consumption
Measured: at 3 and 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Falk Kiefer, Professor, Principal investigator, Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926900
- Sponsor's protocol ID
- SFB636 D6 2006-007090-72
- Acronym
- SFB636D6
- Status last verified
- Nov 2011
- First submitted
- 22 Jun 2009
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strosche A, Zhang X, Kirsch M, Hermann D, Ende G, Kiefer F, Vollstadt-Klein S. Investigation of brain functional connectivity to assess cognitive control over cue-processing in Alcohol Use Disorder. Addict Biol. 2021 Jan;26(1):e12863. doi: 10.1111/adb.12863. Epub 2020 Jan 6.
PubMed 31908107Vollstadt-Klein S, Loeber S, Kirsch M, Bach P, Richter A, Buhler M, von der Goltz C, Hermann D, Mann K, Kiefer F. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial. Biol Psychiatry. 2011 Jun 1;69(11):1060-6. doi: 10.1016/j.biopsych.2010.12.016. Epub 2011 Feb 3.
PubMed 21292243
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
- ClinicalTrials.gov ID
- NCT00926900
- Acronym / sponsor ID
- SFB636D6 / SFB636 D6 2006-007090-72
- Conditions
- Alcohol Drinking
- Keywords
- Alcoholism, D-cycloserine, extinction, cue-exposure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Mar 2009
- Primary completion
- Apr 2012 (estimated)
- First posted
- 24 Jun 2009 (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 explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function.
It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity.
Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine | Active comparator | Drug: D-cycloserine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- current DSM-IV/ ICD-10 diagnosis of alcohol dependence
- controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care
- women (in childbearing age): use of a highly effective method of contraception
- normal or corrected-to-normal vision
- ability to provide written informed consent
Key exclusion criteria (13 listed)
- diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence)
- positive drug screening
- current medication with anti-convulsive or psychotropic drugs
- MRI ineligibility
- sensitivity to study medication as evidenced by a history of adverse drug experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserine50 mg at approximately 1.5 hours prior to cue-exposure training sessions | Drug | D-cycloserine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
Time frame: following completion of cue-exposure therapy
1 secondary outcome
time to first severe relapse to alcohol consumption
Time frame: at 3 and 6 months after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2011.
- Derived from this study: PubMed 31908107Strosche A, Zhang X, Kirsch M, Hermann D, Ende G, Kiefer F, Vollstadt-Klein S. Investigation of brain functional connectivity to assess cognitive control over cue-processing in Alcohol Use Disorder. Addict Biol. 2021 Jan;26(1):e12863. doi: 10.1111/adb.12863. Epub 2020 Jan 6.
- Derived from this study: PubMed 21292243Vollstadt-Klein S, Loeber S, Kirsch M, Bach P, Richter A, Buhler M, von der Goltz C, Hermann D, Mann K, Kiefer F. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial. Biol Psychiatry. 2011 Jun 1;69(11):1060-6. doi: 10.1016/j.biopsych.2010.12.016. Epub 2011 Feb 3.
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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.
Falk Kiefer, Professor principal investigator
Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing D-cycloserine in people with Alcohol Drinking, run by Central Institute of Mental Health, Mannheim at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 28 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Falk Kiefer, Professor (+49 621 1703 3522, falk.kiefer@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging (time frame: following completion of cue-exposure therapy). 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 NCT00926900, which also lists 2 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 Nov 2011.