A study to evaluate how safe is and how well SMO.IR works when given in 4 dose regimens for the maintenance of alcohol abstinence in recently abstinent alcohol-dependent patients
- Conditions
- maintenance of alcohol abstinence in recently abstinent alcohol-dependent patientsMedDRA version: 16.1Level: LLTClassification code 10031519Term: Other and unspecified alcohol dependenceSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2011-000575-14-CZ
- Lead Sponsor
- D&A PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 495
1. Patients must already have signed and dated an informed consent form.
2. Male or female patients of any ethnic group, aged 18 years to 75 years inclusive
and with BMI between 18.5 and 30 kg/m2 inclusive.
3. Patients must meet at least four criteria of alcohol dependence as defined by the
DSM-IV-TR (Appendix 13.4: DSM-IV-TR Criteria for Alcohol Dependence - Diagnostic Code 303.90).
4. Patients must confirm at least 7 drinking days including at least 2 heavy drinking
days in the last 14 days preceding screening. Alcohol drinking will be documented
in TLFB calendar filled retrospectively by the patient at screening visit.
5. Patients who, in the judgment of the investigator, are motivated to completely
abstain from alcohol.
6. Patients must have been abstinent for at least 3 days but up to 14 days with or
without inpatient or outpatient detoxification prior to the randomization. The detoxification treatment benzodiazepine agent, Alcover® (Austria and Italy)
or other) has to be washed out for at least 24 hours prior to the randomization.
7. Patients must be completely abstinent at the time of randomization and the Breath
Alcohol Concentration test must be negative.
8. Patients who provided telephone number of the contact person who could be
contacted in case of patient’s unavailability. The presence of the contact person at
the screening visit is not obligatory.
9. Patients agree to be contacted by the site during the study and provide valid phone contact to the investigator.
10. Laboratory parameters: ASAT and ALAT within 4 times upper limit of normal,
and bilirubin level not greater or equal to 3.6 mg/dl. Other biochemical, urinalysis,
and haematological tests except erythrocyte mean corpuscular volume (MCV)
must be in the normal range or any deviation from the normal range must be rated as non-clinically significant by the investigator. There is no limit for ?-GT.
11. Sexually active female patients must be postmenopausal, surgically sterile, or
practicing an effective method of birth control (e.g., prescription oral
contraceptives, contraceptive injections, intrauterine device, double-barrier
method, contraceptive patch) at least 1 month before study entry and 1 month after the final treatment period. There is no need of contraception for male patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 445
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Abstinence for more than 14 days prior to the randomization.
2. Patients treated with Alcover® in the last 6 months. The wash-out period at least 24 hours between the last Alcover® administration and patient randomization has to be kept.
3. Patients who drunk between screening and randomization visit.
4. Positive urine screen for cannabis, cocaine, heroin, amphetamines, benzodiazepine, barbiturates, methadone, ecstasy, tricyclic antidepressants, other opiates or any other substance of addiction detectable by urinalysis at randomization. Repeat urinalysis is allowed before the time limit for randomization: a repeat positive test is an exclusion criterion.
In the case of patients receiving benzodiazepine (BZD) agents during alcohol
detoxification, a positive BZD urine test will be accepted at randomization, Week 1 and Week 2 visits but at no other visits, provided there is no clinical evidence of BZD
addiction.
5. Current or recent (within 1 year) history of a substance abuse or dependence on benzodiazepine, amphetamines, cocaine, heroin, other opiates or any other substance except nicotine and caffeine as defined by the DSMIV TR (Diagnostic and Statistical Manual of Mental Disorders, fourth edition).
6. History of or current epileptic syndrome with the exception of neonate convulsions.
7. Contra-indication to sodium oxybate: known medical history of succinic
semialdehyde dehydrogenase deficiency.
8. Concomitant psychotropic drugs including anti-epileptic and sedative antihistamine agents.
9. Concomitant treatment with disulfiram, acamprosate, topiramate, baclofen or
naltrexone.
10. Conditions that require treatment with concomitant medications that are not allowed according to the study protocol.
11. Patients with current psychiatric symptoms that meet axis 1 diagnostic criteria on DSM IV and require medication treatment.
12. Patients with psychiatric disorder within the past 6 months that are not clinically
stable and receiving or require any psychotropic medications.
13. Patients with moderate to severe depression measured by Hamilton Depression Scale of 21 points (HAM-D > 15) at the screening visit.
14. Patients with moderate to severe anxiety measured by Hamilton Anxiety Scale of 14 points (HAM-A > 15) at the screening visit.
15. Patients with impaired hepatic function.
16. Patients with impaired renal function
17. Any chronic gastrointestinal disease or previous major abdominal surgery that might affect drug absorption, or elimination.
18. Any significant cerebral vascular and/or cardiovascular disease (e.g., unstable angina pectoris, angina pectoris at rest or for minimal effort, acute myocardial infarction within the last 3 months, heart failure NYHA class II-IV), clinically significant
arrhythmia.
19. Chronic headaches and / or migraine, recurrent nausea and / or vomiting.
20. Patients who have suffered any of the following within 1 year prior to the screening: mild/moderate traumatic brain injury, stroke, transient ischemic attack, brain neoplasm. Severe traumatic brain injury within the last 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either
unconsciousness or posttraumatic amnesia lasting more than 24 h) or residual
sequelae suggesting transient changes in consciousness.
21. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately; for instance, Alzheimer’s disease and any other deme
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method