Alcohol Relapse PreventionPhase 2NCT00561587
Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study
A Phase 2 study testing Seroquel® in people with Alcohol Relapse Prevention and Alcoholism, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.
Trial summary
Due to Quetiapine's particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Relapse Prevention, Alcoholism, Alcohol Drinking
- What is being tested?
- Seroquel®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Feb 2010
- Phase
- Phase 2
- 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
- Alcohol dependence according to ICD-10 and DSM-IV since a minimum of 12 months.
- Detoxified male or female aged between 18 and 65 years.
- Abstinence for a minimum of 7 days and maximum of 21 days before randomization.
- Craving : minimum of 5 points at randomisation (OCDS-G)
- Free informed consent has been given in written form.
- Women of childbearing potential must use a medically accepted method of contraception.
- Only methods with a Pearl-index lower than 1% are regarded as acceptable such as hormonal contraception, surgical sterilization, bilateral ovarectomy, and postmenopause (WHO definition: natural menopause retrospectively for at least one year amenorrhoe) without hormonal replacement therapy within the past 5 months.
Who cannot join
- Patients suffering from psychotic diseases and/or depression with psychotic symptoms and/or demented patients, patients with longlasting continous treatment with psychotropic drugs.
- Known substance abuse other than alcohol or nicotine (except dependence in full remission) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence.
- Hepatitis (GGT or AST three times above normal range).
- An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter.
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- unstable DM defined as enrollment glycosylated hemoglobin (HbA1c)>8.5 %; patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks; patients not under physicians care for DM; physicians responsible for patient´s DM care has not indicated that patient´s DM is controlled; physician responsible for patient´s DM care has not approved patient´s participation in the study; patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to randomization. [For thiazolidinediones (glitazones) this period should not be less than 8 weeks]; patients taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
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- Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- Evidence of clinical relevant disease or clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by study medication or that would affect study medication.
- Patients who, in the investigator's judgment, pose a current serious suicidal risk or have made a suicide attempt within the past 6 months.
- Restricted or complete legal incapacity.
- Additional psychotherapy 1 month prior to randomisation or during participation in the study.
- History of idiopathic orthostatic hypotension, or condition that would predispose to hypotension (e.g. dehydration, hypovolemia).
- Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, C, via blood or other body fluids (as judged by the investigator). Positive HIV-serology in the screening visit.
- Known regular treatment with Quetiapine prior to randomisation.
- Hypersensitivity to Quetiapine or other constituents of the investigational product.
- Simultaneous intake of Cytochrome-P-450-3A4- inducers or inhibitors: Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 2 weeks prior to randomization or during the study period, e.g. the inducers: carbamazepine, phenytoin, barbiturates, rifampicin, rifabutin, glucocorticoids, thioridazine and St. Johns wort, and e.g. the inhibitors: HIV-protease-inhibitors, antimycotics of the azole type (e.g. ketoconazole (except for topical use), itroconazole, fluconazole), erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir
- Female patients who are pregnant or are lactating. Women of childbearing potential not using a medically accepted method of contraception with a Pearl-index > 1%.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Goettingen
Göttingen, Lower Saxony
About this study
Due to Quetiapine's particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind pilot study.
We further want to compare the course of the above mentioned craving and affective symptoms under medication with quetiapine / matching placebo.
Read the detailed description
Naltrexone and Acamprosate are the best evaluated and established therapy options in relapse prevention of alcoholics at present (Litten et al. 1996, Mann et al. 2004). Studies on cue exposure showed that Naltrexone (Monti et al. 1999) and Haloperidol (Modell et al. 1993) block stimuli triggered craving. In addition, they indicate that both may also stop the craving for further alcohol consumption that is induced by a priming dose of alcohol (Modell et al. 1993). However, the clinical relevance of Haloperidol is rather limited due to the risk of extrapyramidal side effects. New atypical dopamine antagonists are reported to have this profile as well, but without the risk of developing extrapyramidal side effects. In a placebo-controlled clinical trial, the atypical antipsychotic Olanzapine has proved to reduce craving for alcohol both after alcohol exposure and a priming dose of alcohol in non-dependent heavy social drinkers (Hutchison et al. 2001). However, Amisulpride in a dose of 50 mg per day failed to prevent alcohol relapse in a double-blind, placebo-controlled study in 71 patients over 6 months (Marra et al. 2002).
- Conditions
- Alcohol Relapse Prevention, Alcoholism, Alcohol Drinking, Alcohol Consumption, Alcohol Abuse
- Being tested
- Seroquel®
- Keywords
- novel antipsychotic, quetiapine, depression, psychopathology
- Medical subject headings
- Alcoholism, Alcohol Drinking, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroquel®Drug
Also called Quetiapine
dosage form: oral, adjusted in the range of 25 to max. 300 mg /day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Seroquel® |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) blood alcohol concentration > 1.0 per mille 2) alcohol consumption > 40 g/day (females) or > 60 g/day (males) 3) continuous intake of alcohol during more than 5 consecutive days (independent of the amount of alcohol)
Measured: 7 month
Secondary outcomes (1)
first consumption of any ethanol,number of drinking and abstinence days,craving measured by the total score of the OCDS-G,STAI,PSQI,depression measured with MADRS and BDI,Amount of total daily cigarette consumption,FTND,CO-breath analysis variance
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Relapse PreventionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Investigators
- Karl Mann, MD PhD, Principal investigator, Dept. of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Mannheim, University of Heidelberg, GermanyBernhard Croissant, MD PhD, Principal investigator, Dept. of Psychiatry and Psychotherapy, Hospital Sigmaringen, University of TuebingenUrsula Havemann-Reinecke, MD PhD, Study director, Department of Psychiatry and Psychotherapy, Georg-August-University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561587
- Sponsor's protocol ID
- 87, 1, 2007_01_30
- Status last verified
- Jan 2008
- First submitted
- 20 Nov 2007
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study
- ClinicalTrials.gov ID
- NCT00561587
- Acronym / sponsor ID
- 87, 1, 2007_01_30
- Conditions
- Alcohol Relapse Prevention, Alcoholism, Alcohol Drinking, Alcohol Consumption, Alcohol Abuse
- Keywords
- novel antipsychotic, quetiapine, depression, psychopathology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 Nov 2007 (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.
Due to Quetiapine's particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind pilot study.
We further want to compare the course of the above mentioned craving and affective symptoms under medication with quetiapine / matching placebo.
Detailed description
Naltrexone and Acamprosate are the best evaluated and established therapy options in relapse prevention of alcoholics at present (Litten et al. 1996, Mann et al. 2004). Studies on cue exposure showed that Naltrexone (Monti et al. 1999) and Haloperidol (Modell et al. 1993) block stimuli triggered craving. In addition, they indicate that both may also stop the craving for further alcohol consumption that is induced by a priming dose of alcohol (Modell et al. 1993). However, the clinical relevance of Haloperidol is rather limited due to the risk of extrapyramidal side effects. New atypical dopamine antagonists are reported to have this profile as well, but without the risk of developing extrapyramidal side effects. In a placebo-controlled clinical trial, the atypical antipsychotic Olanzapine has proved to reduce craving for alcohol both after alcohol exposure and a priming dose of alcohol in non-dependent heavy social drinkers (Hutchison et al. 2001). However, Amisulpride in a dose of 50 mg per day failed to prevent alcohol relapse in a double-blind, placebo-controlled study in 71 patients over 6 months (Marra et al. 2002).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Seroquel® |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Alcohol dependence according to ICD-10 and DSM-IV since a minimum of 12 months.
- Detoxified male or female aged between 18 and 65 years.
- Abstinence for a minimum of 7 days and maximum of 21 days before randomization.
- Craving : minimum of 5 points at randomisation (OCDS-G)
- Free informed consent has been given in written form.
Key exclusion criteria (17 listed)
- Patients suffering from psychotic diseases and/or depression with psychotic symptoms and/or demented patients, patients with longlasting continous treatment with psychotropic drugs.
- Known substance abuse other than alcohol or nicotine (except dependence in full remission) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence.
- Hepatitis (GGT or AST three times above normal range).
- An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter.
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
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 |
|---|---|---|
| Seroquel®Also: Quetiapinedosage form: oral, adjusted in the range of 25 to max. 300 mg /day | Drug | 1 |
Primary outcome
1) blood alcohol concentration > 1.0 per mille 2) alcohol consumption > 40 g/day (females) or > 60 g/day (males) 3) continuous intake of alcohol during more than 5 consecutive days (independent of the amount of alcohol)
Time frame: 7 month
1 secondary outcome
first consumption of any ethanol,number of drinking and abstinence days,craving measured by the total score of the OCDS-G,STAI,PSQI,depression measured with MADRS and BDI,Amount of total daily cigarette consumption,FTND,CO-breath analysis variance
Time frame: 7 month
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 18 Apr 2011.
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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.
Karl Mann, MD PhD principal investigator
Dept. of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Mannheim, University of Heidelberg, Germany
Bernhard Croissant, MD PhD principal investigator
Dept. of Psychiatry and Psychotherapy, Hospital Sigmaringen, University of Tuebingen
Ursula Havemann-Reinecke, MD PhD study director
Department of Psychiatry and Psychotherapy, Georg-August-University, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seroquel® in people with Alcohol Relapse Prevention and Alcoholism, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH 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 7 inclusion and 17 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 18 Apr 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
1) blood alcohol concentration > 1.0 per mille 2) alcohol consumption > 40 g/day (females) or > 60 g/day (males) 3) continuous intake of alcohol during more than 5 consecutive days (independent of the amount of alcohol) (time frame: 7 month). 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 18 Apr 2011.