A Phase III clinical study, performed in several sites to evaluate the efficacy and safety of the drug Lofexidine in opiate addicts (heroin, methadone and buprenorphine)which are expected to participate in a detoxification program.
- Conditions
- Oppiate addicts(heroin, methadone and buprenorphine)MedDRA version: 14.1Level: LLTClassification code 10032707Term: Other specified drug dependence, continuous useSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2011-004775-36-IT
- Lead Sponsor
- GET SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
a)Mail and femal between 18 and 60 years. b)Subjects addicted from heroin follwing DSM-IV criteria, whom have already been decided the inclusion in a fast detoxification program or Subjects addicted from heroin following DSM IV criteria treated with methadone maintenance treatement(< 40 mg/die) o buprenorphine (< 8 mg/die) o buprenorphine/naloxone (< 8 mg/die)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenprphine/naloxone. c) Subjects with positive urine test for heroin and syntesis opiate (methadone, buprenorphine) and negative for other drugs. d) Subjects with laboratory results that must have non clinical significant results that could interfire with the study conduction and evaluation. e) Subjects able to understand and sign the Informed Consent form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a)Subjects with blood pressure < 90/60 mm/Hg and/or in treatement with hypotensive drug. b)Subsects with heart insufficiency(NYHA, classe II)or resting heart frequency < 55 bpm or severe cardiac disorders during anamnesis. c)Subjects with diabetes mellitus. d)Subjects with significant liver disease (AST and/or ALT > 3N). e) Subjects positiv to HBV and /or HCV in pharmacological treatment. f)Subjects with gastric disease that could change the absorption of study drug. g)Subjects with asthma in chronic treatment. h) Subjects with severe psychiatric disorders including psychosis, bipolar disorder, schizophrenia, depression. j)Epileptics or subjects that have been treated with anticonvulsants in the last 3 years. k)Non-compliance during the study, in accordance with the Investigator opinion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: a) To confirm the tollerability and safety profile with the use of Lofexidine during the entire time of treatment. b) To evaluate Lofexidine efficacy undergoing drug free detoxification.;Secondary Objective: To evaluate if Lofexidine standard dosage used in English clinical practice, can be used in italian detoxification centre (Ser.T e/o Presidi delle tossicodipendenze nelle Carceri e/o Unità Operative Ospedaliere)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenorphine/naloxone.;Primary end point(s): a) Frequency and type of adverse events. b) Quantification of withdrawal symptoms by SOWS scale and evaluation of the ''craving'' by VAS scale.;Timepoint(s) of evaluation of this end point: Adverse events will be observed at each visit from the first treatment administration. Withdrawal and ''craving'' will be observed for each day of treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1)Number of patients who completed treatment 2)Number of subjects relapsed to opiate use during follow-up.;Timepoint(s) of evaluation of this end point: 1)Number of patients who completed treatment will be observed at the end of treatment 2)Number of subjects relapsed to opiate use during follow-up will bw observed after the follow-up