AlcoholismPhase 3TEMACANCT03634917
Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence
A Phase 3 study testing Acamprosate Calcium and Calcium Carbonate in people with Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Validation of a Test System to develop new medications for alcoholism (TEMA) The 'TEMA', a progressive-work alcohol self-administration paradigm, can be validated by reproducing the effect of Acamprosate and prove the effect of Calcium to reduce motivation to work for alcohol after 14 - 19 days of treatment during a… 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?
- Acamprosate Calcium and Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2020to 1 May 2024
- 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, who meet or met the diagnostic criteria of an at least mild alcohol use disorder (DSM-5), but do not want to cease alcohol consumption
- willingness to stop alcohol and drug consumption for 15-20 days for the purpose of study participation
- at least high risky alcohol drinkers (WHO) in the Timeline Follow-back Interview over the last 45 day with an average amount of alcohol of 60 g/day (men) or 40 g/day (women) with at least 4 drinking days per week
- informed consent
- ability to swallow a placebo capsule
- not more than 6 consecutive alcohol abstinent days between screening and visit 2
Who cannot join
- Current Substance dependence (illegal drugs) ICD-10 or DSM-IV
- Intention to stop alcohol consumption immediately and permanently
- Current or previous disease that could cause a clinically relevant hazard (e.g. pancreatitis, cirrhosis)
- kidney stone disease
- Current Treatment with psychotropic drugs or current psychiatric disorder in need of treatment
- alcohol withdrawal symptoms (at Screening, visit 1 or visit 2) with CIWA-Ar-Score > 6 points or arterial blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg or heart rate >105 bpm (when breath alcohol concentration 0 mg%)
Show all 22Show fewer
- history of epileptic seizure or delirium
- routine laboratory parameters, indicating relevant liver-, pancreas- or kidney injury, an acute infection, anemia or lack of vitamins (ASAT, ALAT, lipase > threefold of the standard at screening, Quick's value < 70%, creatinine > 120 µmol/l, eGFR < 30 mol/min/1.73 m², leucocytes > 13000/µl, haemoglobin < 7.5 mmol/l (men) or 6.5 mmol/l (women), MCV > 105 fl, calcium level at screening > 2.7 mmol/l
- body weight > 120 kg (Screening)
- Breath alcohol concentration at screening or visit 1 or visit 2 two times > 0 mg% or drug screening two times positive for opiate, cannabis, cocaine, amphetamine, benzodiazepine
- history of hypersensitivity to alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures
- history of inefficient treatment with Acamprosate
- participation in another clinical trial within the last 4 weeks before inclusion
- 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)
- participant is not expected to comply with the protocol (for example lacking compliance)
- less than 200 cumulative work trials for alcohol (in constant attention task) on 1st alcohol self-administration day
- specific contraindications for Acamprosate or Calcium Carbonate (according prescribing information)
- hypercalcemia, e.g. due to hyperparathyroidism, overdosage vitamin D, paraneoplastic
- renal insufficiency (eGFR < 30ml/min/1.73m²), creatinine >120 µmol/l
- intake of Vitamin D compounds or cardioactive glycosides
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Psychiatrie und Psychotherapie; Technische Universität Dresden
Dresden, Saxony, 01307
About this study
Official title: Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence (TEMACA)
Validation of a Test System to develop new medications for alcoholism (TEMA)
The 'TEMA', a progressive-work alcohol self-administration paradigm, can be validated by reproducing the effect of Acamprosate and prove the effect of Calcium to reduce motivation to work for alcohol after 14 - 19 days of treatment during a period of 15 - 20 days of alcohol abstinence in a randomized, double-blind, placebo-controlled three-arm parallel-group design.
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.
84 at least high risky drinkers (WHO) with at least mild alcohol use disorder perform two alcohol self-administration experiments, one before and one after 14-19 days of randomized double-blinded treatment with Acamprosate, Calcium Carbonate or Placebo.
Each alcohol request requires prior work in a constant attention task according to a progressive schedule to earn the next alcohol infusion.
Secondary objectives refer to investigations, whether
- administration of Acamprosate or Calcium Carbonate in comparison to placebo leads to a change in perception of subjective alcohol effects
- effectiveness of Acamprosate or Calcium can be predicted by calcium parameters (baseline and changes during medication period)
- administration of Acamprosate or Calcium leads to a reduction in alcohol craving
- Frequency of alcohol consumption during the imposed abstinence period differs between treatment groups and influences primary outcome
- study participation modifies motivation to change drinking habits and utilization of addiction care services
- Acid sphingomyelinase (ASM) activities are applicable as biomarker and predictor of medication effects.
- safety issues occur due to study medication
- Conditions
- Alcoholism
- Being tested
- Acamprosate Calcium, Calcium Carbonate, Placebo, Placebo lead in
- Keywords
- Acamprosate, Calcium, 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.
Acamprosate CalciumDrug
Also called Campral
1 capsule with 666 mg Acamprosate
Calcium CarbonateDrug
Also called Calcium
1 capsule with 1500 mg Calcium Carbonate
PlaceboDrug
1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)
Placebo lead inDrug
1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Active comparator | 1 capsule with Acamprosate calcium
* oral use
* 3 times / day (morning, noon, evening)
* 666 mg per capsule
* 14 - 19 days Receives: Drug: Acamprosate Calcium; Drug: Placebo lead in |
| Calcium Carbonate | Active comparator | 1 capsule with Calcium Carbonate
* oral use
* 3 times / day (morning, noon, evening)
* 1500 mg Calcium Carbonate (= 600 mg Calcium 2+)
* 14 - 19 days Receives: Drug: Calcium Carbonate; Drug: Placebo lead in |
| Placebo | Placebo comparator | 1 capsule placebo,
* oral use
* 3 times / day (morning, noon, evening)
* 14 - 19 days Receives: Drug: Placebo; Drug: Placebo lead in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day
Each alcohol request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next alcohol infusion.
Primary outcome measure is the difference in the cumulative number of work sets for alcohol in the "constant attention task" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5).
Comparison between:
- Acamprosate and Placebo and
- Calcium Carbonate and Placebo
Measured: 18 to 31 days between 1st and 2nd measurement
Secondary outcomes (16)
Difference between "break points" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day
The "break point" is the number of the last alcohol request before subjects stop to work for more alcohol.
Measured: 18 to 31 day between 1st and 2nd measurement
Difference between max. achieved blood alcohol concentrations (BAC) on 1st alcohol self-administration (ASA) day and 2nd ASA day
Max. BAC during alcohol self-administration
Measured: 18 to 31 day between 1st and 2nd measurement
Difference between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Sodium chloride is an alternative reinforcer on alcohol self-administration.
Each Sodium chloride request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next sodium chloride infusion.
Outcome measure is the difference in the cumulative number of work sets for sodium chloride (as an alternative reinforce) in the "constant attention task" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5).
Measured: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day of 1st and 2nd half of self-administration periods.
Each alcohol request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next alcohol infusion.
Outcome measure is the difference in the cumulative number of work sets for alcohol in the "constant attention task" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately
Measured: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between "break points" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.
The "break point" is the number of the last alcohol request before subjects stop to work for more alcohol.
Outcome measure is the the difference in break points for alcohol between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately.
Measured: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between max. achieved blood alcohol concentrations (BAC) for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Outcome measure is the the difference in max. achieved blood alcohol concentrations between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately.
Measured: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Sodium chloride is an alternative reinforcer on alcohol self-administration.
Each Sodium chloride request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next sodium chloride infusion.
Outcome measure is the difference in the cumulative number of work sets for sodium chloride in the "constant attention task" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately
Measured: 18 to 31 days between 1st and 2nd measurement
Differences between subjective alcohol effects on 1st ASA day and 2nd ASA day
alcohol-induced changes in stimulation, sedation, negative alcohol effects, craving, well-being, subjective feeling of drunkenness, subjective number of drinks and thirst measured with visual analogue scales ("Quizzer") before, 2 x during and after the alcohol infusion period.
scale ranges: minimum = 0 to maximum = 100
Higher values on a scale represent an increase of aforementioned subjective alcohol effects.
Comparison between 1st ASA and 2nd ASA day
Measured: 18 to 31 days between 1st and 2nd measurement
Calcium parameters on 1st ASA and 2nd ASA day
magnesium, phosphate, total calcium, albumin, parathormone, 25-hydroxyvitamin D measurement at baseline and difference between 2nd and 1st ASA
Measured: 18 to 31 day between 1st and 2nd measurement
Alcohol craving (OCDS) "Obsessive Compulsive Drinking Scale" (OCDS)
Craving measured with "Obsessive Compulsive Drinking Scale" (OCDS) before 1st and 2nd ASA The OCDS is a 14-item self-rating instrument. It provides a total and two subscale (1: obsessive, 2. compulsive) scores, that measure aspects of alcohol craving.
Measured: 18 to 31 days between 1st and 2nd measurement
Violation of imposed alcohol abstinence
in % of the days with alcohol consumption (measured with timeline follow-back, measured at visit 5)
Measured: 15-20 days (abstinence period)
Readiness to change
"Readiness to change" questionnaire 12-item instrument for measuring the "stage of change" at screening, visit 6 and follow-up.
The test has three four-item subscales to allocate patients to a stage of change: pre-contemplation (P), contemplation (C) or action (A), based on the stages of change model (by Prochaska and DiClementel)
Answers are given on a scale ranging from 'strongly disagree' ("-2") through "0" to to 'strongly agree' (+2) . The range for each subscale is -8 to +8.
Each subject is allocated to the stage on which it reached the highest score.
Measured: 39 - 90 days between screening and visit 6, 6-8 weeks between visit 6 and follow-up
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 (measured at visits 1, 3, 5, 6 and follow-up)
- % drinking days, b) average amount of alcohol per drinking day, c) % of binge days (alcohol consumption over 60 g /d (men) or 48 g / d (women)), d) average amount of alcohol per binge day,
Measured: 39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6
utilization of addiction care services
does the subject frequent addiction care services at Screening, visit 6 and follow-up
Measured: 39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6
Acid sphingomyelinase (ASM) activities
analysis in serum at screening at visits 2 and 5, before and after alcohol self-administration
Measured: screening, 18 to 31 day between 1st and 2nd measurement, 2.5 hours from begin to end of ASA
Acamprosate blood level
measured on 2nd ASA day (visit 5)
Measured: one-time measurement after 14 - 19 days of medication intake (at visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start5 Aug 2020
- Primary completion30 Aug 2023
- Study completion1 May 2024
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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634917
- Sponsor's protocol ID
- TUD-TEMACA-069
- Acronym
- TEMACA
- Status last verified
- May 2024
- First submitted
- 25 Jul 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence (TEMACA)
- ClinicalTrials.gov ID
- NCT03634917
- Acronym / sponsor ID
- TEMACA / TUD-TEMACA-069
- Conditions
- Alcoholism
- Keywords
- Acamprosate, Calcium, alcohol self-administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
Validation of a Test System to develop new medications for alcoholism (TEMA)
The 'TEMA', a progressive-work alcohol self-administration paradigm, can be validated by reproducing the effect of Acamprosate and prove the effect of Calcium to reduce motivation to work for alcohol after 14 - 19 days of treatment during a period of 15 - 20 days of alcohol abstinence in a randomized, double-blind, placebo-controlled three-arm parallel-group design.
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.
84 at least high risky drinkers (WHO) with at least mild alcohol use disorder perform two alcohol self-administration experiments, one before and one after 14-19 days of randomized double-blinded treatment with Acamprosate, Calcium Carbonate or Placebo.
Each alcohol request requires prior work in a constant attention task according to a progressive schedule to earn the next alcohol infusion.
Secondary objectives refer to investigations, whether
- administration of Acamprosate or Calcium Carbonate in comparison to placebo leads to a change in perception of subjective alcohol effects
- effectiveness of Acamprosate or Calcium can be predicted by calcium parameters (baseline and changes during medication period)
- administration of Acamprosate or Calcium leads to a reduction in alcohol craving
- Frequency of alcohol consumption during the imposed abstinence period differs between treatment groups and influences primary outcome
- study participation modifies motivation to change drinking habits and utilization of addiction care services
- Acid sphingomyelinase (ASM) activities are applicable as biomarker and predictor of medication effects.
- safety issues occur due to study medication
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acamprosate | Active comparator | Drug: Acamprosate Calcium, Drug: Placebo lead in1 capsule with Acamprosate calcium * oral use * 3 times / day (morning, noon, evening) * 666 mg per capsule * 14 - 19 days |
| Calcium Carbonate | Active comparator | Drug: Calcium Carbonate, Drug: Placebo lead in1 capsule with Calcium Carbonate * oral use * 3 times / day (morning, noon, evening) * 1500 mg Calcium Carbonate (= 600 mg Calcium 2+) * 14 - 19 days |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Placebo lead in1 capsule placebo, * oral use * 3 times / day (morning, noon, evening) * 14 - 19 days |
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, who meet or met the diagnostic criteria of an at least mild alcohol use disorder (DSM-5), but do not want to cease alcohol consumption
- willingness to stop alcohol and drug consumption for 15-20 days for the purpose of study participation
- at least high risky alcohol drinkers (WHO) in the Timeline Follow-back Interview over the last 45 day with an average amount of alcohol of 60 g/day (men) or 40 g/day (women) with at least 4 drinking days per week
- informed consent
- ability to swallow a placebo capsule
Key exclusion criteria (22 listed)
- Current Substance dependence (illegal drugs) ICD-10 or DSM-IV
- Intention to stop alcohol consumption immediately and permanently
- Current or previous disease that could cause a clinically relevant hazard (e.g. pancreatitis, cirrhosis)
- kidney stone disease
- Current Treatment with psychotropic drugs or current psychiatric disorder in need of treatment
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 |
|---|---|---|
| Acamprosate CalciumAlso: Campral1 capsule with 666 mg Acamprosate | Drug | Acamprosate |
| Calcium CarbonateAlso: Calcium1 capsule with 1500 mg Calcium Carbonate | Drug | Calcium Carbonate |
| Placebo1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate) | Drug | Placebo |
| Placebo lead in1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate) | Drug | Acamprosate, Calcium Carbonate, Placebo |
Primary outcome
Difference between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day
Time frame: 18 to 31 days between 1st and 2nd measurement
Each alcohol request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next alcohol infusion. Primary outcome measure is the difference in the cumulative number of work sets for alcohol in the "constant attention task" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5). Comparison between: 1. Acamprosate and Placebo and 2. Calcium Carbonate and Placebo
16 secondary outcomes
Difference between "break points" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day
Time frame: 18 to 31 day between 1st and 2nd measurement
Difference between max. achieved blood alcohol concentrations (BAC) on 1st alcohol self-administration (ASA) day and 2nd ASA day
Time frame: 18 to 31 day between 1st and 2nd measurement
Difference between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Time frame: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day of 1st and 2nd half of self-administration periods.
Time frame: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between "break points" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Time frame: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between max. achieved blood alcohol concentrations (BAC) for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Time frame: 18 to 31 days between 1st and 2nd measurement
Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.
Time frame: 18 to 31 days between 1st and 2nd measurement
Differences between subjective alcohol effects on 1st ASA day and 2nd ASA day
Time frame: 18 to 31 days between 1st and 2nd measurement
Calcium parameters on 1st ASA and 2nd ASA day
Time frame: 18 to 31 day between 1st and 2nd measurement
Alcohol craving (OCDS) "Obsessive Compulsive Drinking Scale" (OCDS)
Time frame: 18 to 31 days between 1st and 2nd measurement
Violation of imposed alcohol abstinence
Time frame: 15-20 days (abstinence period)
Readiness to change
Time frame: 39 - 90 days between screening and visit 6, 6-8 weeks between visit 6 and follow-up
Drinking habits
Time frame: 39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6
utilization of addiction care services
Time frame: 39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6
Acid sphingomyelinase (ASM) activities
Time frame: screening, 18 to 31 day between 1st and 2nd measurement, 2.5 hours from begin to end of ASA
Acamprosate blood level
Time frame: one-time measurement after 14 - 19 days of medication intake (at visit 5)
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 29 May 2024.
Related trials for Alcoholism
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acamprosate Calcium and Calcium Carbonate 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 22 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 29 May 2024. 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 between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day (time frame: 18 to 31 days between 1st and 2nd measurement). 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 29 May 2024.