Development of a morphine-naloxone combination.

Phase 1

• Conditions: Treatment of opioid dependence; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2011-005903-34-AT
• Lead Sponsor: G. L. Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Male, over the age of 18 years
- meet DSM-IV criteria for the diagnosis of opioid dependence currently undergoing morphine mainteinance treatment,
- with a history of regular opioid abuse,
- under opioid maintenance treatment for opioid abuse with morphine (occasionally injecting heroin) with a constant dose for = 1 month,
- in good health and have venous access sufficient for i.v. drug administration
- with assessed normal QTc time (Bazzett corrected <500ms),
- negative urine test (except for THC- tetrahydrocannabinol, marijuana” and opioids)
- agree to be admitted to the inpatient research unit for a minimum of 7 days, and be able to complete all protocol-specified assessments,
- signed written informed consent.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- with clinically significant somatic illnesses (except stable chronic hepatitis),
- with acute psychotic illnesses, i.e. known schizophrenia, major depression with suicidal intent,
- with opioid maintenance treatment with morphine at variable doses or for a period of < 1 month,
- with daily alcohol consumption of > 100 g during the last 4 weeks,
- with cocaine dependence,
- showing contraindications to morphine (known hypersensitivity to opioids, restricted respiratory function, serious impairment of liver and/or kidney function, inter alia),
- uncooperative patients, unwilling to follow instructions by the Investigator,
- patients scheduled for any major surgery or intervention, which would fall within the study period,
- patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry,
- patients who, in the opinion of the Investigator, are unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria,
- with imprisonment or under criminal prosecution for the following
4 week-period,
- with incapacitation and court appointment.
- with documented (ultrasound or right heart catheter) heart failure (NYHA >II)
- with documented (ECG) history of cardiac arrhythmia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified