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: 15.0Level: LLTClassification code 10031519Term: Other and unspecified alcohol dependenceSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2011-000575-14-ES
- 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 28 kg/m2 inclusive.
3. Patients must meet at least four criteria of alcohol dependence as defined by the DSM-IV-TR.
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. Treatment of withdrawal with Alcover® at the time of study entry and/or during screening period is allowed. 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 and Week 1 visits but at no other visits, provided there is no clinical evidence of BZD addiction.
5. Current or recent 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 DSM-IV TR
6. History of or current epileptic syndrome 7. 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
18. Any significant cerebral vascular and/or cardiovascular disease
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 lasting or residual sequelae suggesting transient changes in consciousness.
21. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately.
22. Any clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise the patient?s safety during trial participation
23. History of malignancy within the past 2 years, with the exception of basal cell skin carcinoma and cervical cancer in situ with normal pap smear.
24. Patient who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development.
25. Patients prot
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the efficacy of SMO.IR in the maintenance of alcohol abstinence in recently abstinent alcohol-dependent patients.;Primary end point(s): The primary efficacy endpoint will be the Percentage of Days Abstinent (PDA) at the end of the study. The PDA is calculated as the ratio expressed as a percentage of the number of days with no alcohol intake to the number of days corresponding to the Double-blind treatment phase (84 days).;Timepoint(s) of evaluation of this end point: at the end of the study;Secondary Objective: · To assess the safety of SMO.IR in this patient population including possible GHB<br>craving or withdrawal reaction, abuse or misuse.<br>· To assess the effect of SMO.IR on other clinically relevant secondary efficacy endpoints.<br>· To compare the safety and efficacy of 4 dose regimens of SMO.IR in order to define the optimal dose of SMO.IR in this indication i.e. the dose of SMO.IR associated with the highest benefit-to-risk ratio.
- Secondary Outcome Measures
Name Time Method