AlcoholismPhase 3TEMANXNCT02652585
Validation of a Test System for Development of Medications for Alcoholism
A Phase 3 study testing Naltrexone in people with Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to 4 Sep 2017
- Phase
- Phase 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female volunteers aged 25 to 55 years
- at least weekly alcohol consumption at a medium risk level according to WHO in the Timeline Follow-back Interview over the last 45 day with an average amount of alcohol of 41 g/day (men) or 31 g/day (women)
- at least 6 days with an alcohol consumption of >100 g/day (men) or 75 g/day (women) and at least 4 non consecutive alcohol abstinent days in the last 45 days
- at least 1 drinking day in each full week between screening and visit 1 and not more than 6 abstinent days in the week before visit 1
- no demand of treatment of the risky alcohol consumption
- written consent after Information
Who cannot join
- a history of hypersensitivity against alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures
- participation in another clinical trial within the last 4 weeks before inclusion
- addiction or other disorders, which will not allow the subject to assess the character and importance or possible consequences of the clinical trial
- pregnant or breastfeeding women
- women capable of bearing children, except women who fulfil following criteria:- post-menopausal (12 months natural amenorrhoea or 6 month amenorrhoea and Serum FSH >40 ml U/ml) - post operative (6 weeks after ovariectomy on both sides with or without hysterectomy) - regular and correct use of a contraceptive method with an error Quote of < 1 % per year (for example implants, depot injections, oral contraceptive, IUP). It has to be recognized that a combined oral contraception - in contrast to pure progesterone compounds - have a failure rate of < 1 %. Hormone IUDs with a Pearl Index of 1 % are safer than copper IUDs. - sexual abstinence - vasectomy of the Partner
- evidence that the participant is not expected to comply with the protocol (for example lacking compliance)
Show all 20Show fewer
- current or previous alcohol or substance dependence according to DSM-IV (exception: tobacco dependence)
- current or previous treatment because of alcohol, for example in an addiction advisory cen-tre, self-help group, detoxification treatment
- current or previous diseases, where an alcohol infusion can cause a clinically relevant hazard (e. g. pancreatitis, liver cirrhosis)
- current or planned intake of opiate analgesics
- current psychiatric treatment or intake of psychiatric drug or suffering from of a psychiatric disease requiring treatment
- a history of suicide attempt
- CIWA-Score >5 at Screening (alcohol withdrawal scale)
- a history of symptoms of alcohol withdrawal, epileptic seizures or delirium
- routine laboratory Parameters, indicating relevant liver-, pancreas- or kidney injury, an acute infection, anaemia or lack of vitamins (ASAT, ALAT > twofold of the standard at screening, gamma-GT, lipase >threefold of the standard, CRP < 15 mg/l, creatin indicating a moderate renal insufficiency ( eGFR <60 ml/min), leucocytes > 12000/µl, haemoglobin < 7,5 mmol/l (men) or 6,5 mmol/l (women), MCV > 100 fl)
- Body weight > 130 kg
- drug screening in urine: once positive at screening for opiate, cannabis, cocaine, amphetamines, benzodiazepines or positive once at visit 1 for opiates or positive twice at visit 1 for cannabis, cocaine, amphetamines, benzodiazepines
- breath alcohol concentration at screening once > 0,00 g/kg or twice >0,00 g/kg at visit 1
- unsuitable for fMRT (e. g. cardiac pacemaker, claustrophobia)
- specific contraindications against naltrexone: o acute hepatitis o severe or acute liver disease o severe kidney disease o rare hereditary galactose intolerance, Lapp-lactase-deficiency or Glucose-galactose-malabsorption
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Dresden, 01307
About this study
Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.
Read the detailed description
Objective of this study is to show that a laboratory alcohol self-administration method can predict the therapeutic potential of new compounds to reduce relapse in alcohol-dependent patients.
The 'TEMA" translates several animal behavioral paradigms of alcohol self-administration into corresponding human experiments.
We will investigate the opiate antagonist Naltrexone, whose anti-relapse effect is well documented, as a reference drug for validation.
Main objective:
With TEMA (test system for development of medications for alcoholism ) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.
Secondary objectives:
- administration of naltrexone in comparison to placebo leads to a reduction of alcohol craving and real-life drinking
- administration of naltrexone in comparison to placebo leads to reduction of the CDT-Level
- administration of naltrexone in comparison to placebo leads to a change in perception of subjective alcohol effects
- the effectiveness of naltrexone can be predicted by the A118G polymorphism of the OPRM1
- administration of naltrexone changes the baseline and alcohol-induced ability of motor inhibition
- administration of naltrexone changes the baseline and alcohol-induced regional cerebral perfusion
- administration of naltrexone changes the baseline and alcohol-induced cerebral resting state activity
- changes of alcohol effects to the brain activity induced by naltrexone in comparison to placebo correlate with effects of naltrexone on the willingness to work for alcohol self-administration
- Conditions
- Alcoholism
- Being tested
- Naltrexone, Placebo
- Keywords
- Alcoholism, alcohol self-administration
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Adepend
PlaceboDrug
capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | 1 capsule naltrexone 25 mg per day, oral use, day 1 to day 3;
1 capsule naltrexone 50 mg per day, oral use, day 4 to day 28 Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | 1 capsule placebo, oral use, day 1 to day 28 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference CAT Trials alcohol
Difference of cumulative number of work sets for alcohol in the "constant attention task" between first measurement (without medication) and second measurement (with medication)
Measured: one year
Secondary outcomes (18)
Difference CAT Trials sodium chloride solution
Difference of cumulative number of work sets for sodium chloride solution in the "constant attention task" between first measurement (without medication) and second measurement (with medication)
Measured: one year
break Point alcohol
Difference of the "break point" in the "progressive work" schedule for the work for alcohol between first measurement (without medication) and second measurement (with medication). The "break point" is the number of the last alcohol request before subjects stop to work for more alcohol.
Measured: one year
max. BAC
Maximal achieved blood alcohol concentration (BAC) in alcohol self-administration between first measurement (without medication) and second measurement (with medication)
Measured: one year
Drinking habits
Drinking habits measured with Timeline Follow-back Interview over 45 days before study start (measured at screening) and over the entire study duration (between screening and the last day of medicinal product intake, ascertained at visit 5): drinking days, amount of alcohol per drinking day and number of days with alcohol consumption over 60 g (men) or 48 g (women)
Measured: one year
CDT - level
CDT - level: (carbohydrate-deficient transferrin), measured at visit 1 and visit 5
Measured: one year
alcohol craving
Alcohol craving in daily routine (OCD - scale) measured at visit 1 and visit 4
Measured: one year
subjective alcohol effects
Difference in subjective alcohol effects between first measurement (without medication) and second measurement (with medication), measured with visual analogue scales ("Quizzer") before, during and after the alcohol infusion
Measured: one year
motor impulse control
Capacity for motor impulse control during infusion of physiologic saline solution or alcohol as NIMPs (single-blinded), measured with the counting stroop task (in Verum and placebo group) at visit 3 and 4
Measured: one year
cerebral blood flow (CBF)
Regional cerebral perfusion in ml/100 g tissue per Minute during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with arterial spin labeling (ASL) under verum or placebo condition at visit 3 and 4
Measured: one year
Cerebral resting state activity
Cerebral resting state activity during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with BOLD fMRI (in Verum and placebo group) at visit 3 and 4
Measured: one year
adverse events
Medical survey concerning occurring adverse events at visit 1 to 5
Measured: one year
ALAT
ALAT (alanine aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
Measured: one year
ASAT
ASAT (aspartate aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
Measured: one year
Gamma-GT
Gamma-GT in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)
Measured: one year
standard blood cell count
standard blood cell count before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
Measured: one year
creatinine
creatinine in µmol/l before inclusion (screening visit)
Measured: one year
lipase
lipase in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)
Measured: one year
CRP
CRP (C-reactive protein) in mg / l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion25 Aug 2017
- Study completion4 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich S Zimmermann, MD, Study director, Klinik und Poliklinik für Psychiatrie und Psychotherapie Unversitätsklinikum Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652585
- Sponsor's protocol ID
- TUD-TEMANX-065
- Acronym
- TEMANX
- Status last verified
- Sep 2017
- First submitted
- 6 Jan 2016
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Test System for Development of Medications for Alcoholism
- ClinicalTrials.gov ID
- NCT02652585
- Acronym / sponsor ID
- TEMANX / TUD-TEMANX-065
- Conditions
- Alcoholism
- Keywords
- Alcoholism, alcohol self-administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 12 Jan 2016 (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.
Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.
Detailed description
Objective of this study is to show that a laboratory alcohol self-administration method can predict the therapeutic potential of new compounds to reduce relapse in alcohol-dependent patients.
The 'TEMA" translates several animal behavioral paradigms of alcohol self-administration into corresponding human experiments.
We will investigate the opiate antagonist Naltrexone, whose anti-relapse effect is well documented, as a reference drug for validation.
Main objective:
With TEMA (test system for development of medications for alcoholism ) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.
Secondary objectives:
- administration of naltrexone in comparison to placebo leads to a reduction of alcohol craving and real-life drinking
- administration of naltrexone in comparison to placebo leads to reduction of the CDT-Level
- administration of naltrexone in comparison to placebo leads to a change in perception of subjective alcohol effects
- the effectiveness of naltrexone can be predicted by the A118G polymorphism of the OPRM1
- administration of naltrexone changes the baseline and alcohol-induced ability of motor inhibition
- administration of naltrexone changes the baseline and alcohol-induced regional cerebral perfusion
- administration of naltrexone changes the baseline and alcohol-induced cerebral resting state activity
- changes of alcohol effects to the brain activity induced by naltrexone in comparison to placebo correlate with effects of naltrexone on the willingness to work for alcohol self-administration
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: Naltrexone1 capsule naltrexone 25 mg per day, oral use, day 1 to day 3; 1 capsule naltrexone 50 mg per day, oral use, day 4 to day 28 |
| Placebo | Placebo comparator | Drug: Placebo1 capsule placebo, oral use, day 1 to day 28 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male and female volunteers aged 25 to 55 years
- at least weekly alcohol consumption at a medium risk level according to WHO in the Timeline Follow-back Interview over the last 45 day with an average amount of alcohol of 41 g/day (men) or 31 g/day (women)
- at least 6 days with an alcohol consumption of >100 g/day (men) or 75 g/day (women) and at least 4 non consecutive alcohol abstinent days in the last 45 days
- at least 1 drinking day in each full week between screening and visit 1 and not more than 6 abstinent days in the week before visit 1
- no demand of treatment of the risky alcohol consumption
Key exclusion criteria (20 listed)
- a history of hypersensitivity against alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures
- participation in another clinical trial within the last 4 weeks before inclusion
- addiction or other disorders, which will not allow the subject to assess the character and importance or possible consequences of the clinical trial
- pregnant or breastfeeding women
- women capable of bearing children, except women who fulfil following criteria:- post-menopausal (12 months natural amenorrhoea or 6 month amenorrhoea and Serum FSH >40 ml U/ml) - post operative (6 weeks after ovariectomy on both sides with or without hysterectomy) - regular and correct use of a contraceptive method with an error Quote of < 1 % per year (for example implants, depot injections, oral contraceptive, IUP). It has to be recognized that a combined oral contraception - in contrast to pure progesterone compounds - have a failure rate of < 1 %. Hormone IUDs with a Pearl Index of 1 % are safer than copper IUDs. - sexual abstinence - vasectomy of the Partner
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 |
|---|---|---|
| NaltrexoneAlso: Adepend | Drug | Naltrexone |
| Placebocapsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule | Drug | Placebo |
Primary outcome
Difference CAT Trials alcohol
Time frame: one year
Difference of cumulative number of work sets for alcohol in the "constant attention task" between first measurement (without medication) and second measurement (with medication)
18 secondary outcomes
Difference CAT Trials sodium chloride solution
Time frame: one year
break Point alcohol
Time frame: one year
max. BAC
Time frame: one year
Drinking habits
Time frame: one year
CDT - level
Time frame: one year
alcohol craving
Time frame: one year
subjective alcohol effects
Time frame: one year
motor impulse control
Time frame: one year
cerebral blood flow (CBF)
Time frame: one year
Cerebral resting state activity
Time frame: one year
adverse events
Time frame: one year
ALAT
Time frame: one year
ASAT
Time frame: one year
Gamma-GT
Time frame: one year
standard blood cell count
Time frame: one year
creatinine
Time frame: one year
lipase
Time frame: one year
CRP
Time frame: one year
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 27 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ulrich S Zimmermann, MD study director
Klinik und Poliklinik für Psychiatrie und Psychotherapie Unversitätsklinikum Carl Gustav Carus Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone in people with Alcoholism, run by Technische Universität Dresden 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 6 inclusion and 20 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 27 Sep 2017. 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 phase mean?
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?
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?
Difference CAT Trials alcohol (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2017.