Safety & Efficacy of 2 Alternative Forms of Oral Buprenorphine (v10)
- Conditions
- Opioid dependencyMedDRA version: 14.1 Level: LLT Classification code 10001125 Term: Addiction System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2012-003560-49-GB
- Lead Sponsor
- Macarthys Laboratories Limited (trading as Martindale Pharma)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
1. Clinical condition: Opioid-dependent patients, eligible for opioid substitution therapy.
2. Gender: Male and Female.
3. Age: =18 - =60 years.
4. BMI: =18.0 to =30.0 Kg/m2.
5. Capable of providing voluntary informed consent.
6. For female subjects of child-bearing potential an adequate form of contraception must be adhered to for at least 30 days prior to trial entry however, this requirement may be waived if there have been two negative serum pregnancy tests at least seven days apart before being dosed with buprenorphine (e.g. at screening and prior to the first buprenorphine dose). The patient must adhere to a contraceptive regimen continuously until 30 days after the last Extension Period visit.
Adequate contraception is defined as:
a. The usage by the female subject/partner of any hormonal contraception or intra-uterine device (which should be established prior to the start of the trial), plus usage by at least one of the partners of an additional spermicide-containing barrier method of contraception.
b. The use of a barrier method alone or abstinence is not considered adequate.
c. Females of non-child-bearing potential i.e., postmenopausal, must be amenorrhoeic for at least 2 years AND have a serum follicle stimulating hormone (FSH) level of at least 30 IU/L, or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable).
7. A non-custodial stable residence and telephone number.
8. For patients enrolling in the pharmacokinetic part of the study venous access must be suitable for the collection of serial blood samples. All other subjects should have venous access adequate for the collection of all required study samples using conventional techniques.
9. No treatment with either buprenorphine or methadone within one day of receiving study treatment. If potential study subjects do not meet this criterion patients can enter a Pre-randomisation Management Period. During this period buprenorphine and methadone will be excluded for at least one day. Where necessary, interim treatment with oral morphine (either as slow-release or standard oral immediate release morphine) will be provided.
10. The screening ECG should be normal or have no clinically significant abnormalities.
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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Hypersensitivity to buprenorphine or any other component of the oral lyophilisate.
2. Dependent use of cocaine and amphetamines requiring specific treatment
3. .Regular use of other opioids from 24 hours prior to the first dose of buprenorphine until the end of the study.
4. Severe hepatic insufficiency (defined as liver function tests, including alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, greater than three times the upper limit of normal).
5. Patients suffering from severe respiratory insufficiency.
6. Patients suffering from acute alcoholism or delirium tremens.
7. Habitual or dependent use of benzodiazepines, which may potentiate respiratory depression, above recommended therapeutic doses or patients who are taking benzodiazepines erratically.
8. Concomitant medication known to interact with buprenorphine.
9. Administration of any approved or investigational long-acting injections of antipsychotic medications.
10. Current psychiatric diagnosis of major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the patient's ability to complete the study.
11. Female patients with a positive pregnancy test, lactating mother, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial.
12. Participation in a clinical trial of a pharmacological agent within 6 months of screening.
13. Any other factor that in the opinion of the Investigator would make the patient unsafe or unsuitable for the study.
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