Morphine Slow-release Capsules in Substitution Therapy

NCT01079117 | Completed Phase 3

• 2 other identifiers: SUB90012008-002185-60
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone

Conditions

Opiate Dependent

Keywords

Opiate; Methadone; Slow Release Oral Morphine (SORM); Sevre-Long™

Outcome Measures

Primary Outcomes (1)

• Proportion of positive urine tests for by-consumption of target substances per subject

  The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject. Target substances are defined as all opioids except the study drug. The proportions are compared between substitution with methadone and SROM treatment in a crossover design.

  each week during the 22 week cross-over phase

Secondary Outcomes (10)

• Secondary Outcome Measures

  throughout the 22 week cross over period

• By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines)

  throughout the 22 week cross over period

• Occurring psychopathological and somatic symptoms.

  througout the 22 week cross over period

• Effect of treatment on the ECG (QTc prolongation)

  throughout the 22 week cross over phase

• Group characterisation of patients that is keen to change the medication

  throughout the 22 week cross over period

Study Arms (2)

Sevre-Long™

ACTIVE COMPARATOR

slow release oral morphine

Drug: Sevre-Long™; Drug: Slow release oral morphine

Methadone

ACTIVE COMPARATOR

Methodone

Drug: Methadone

Interventions

Sevre-Long™ DRUG

The subjects will be randomised to either 10 weeks of treatment with methadone or SROM. After an adjustment phase of one week they first will be medicated for 10 weeks with the treatment to which they have been randomised. The cross-over, in which all subjects change to their opposite treatment, will serve for an additional adjustment phase of one week. After the second and new adjustment phase they are treated for 10 weeks with the newly adjusted medication. After the end of week 22 all participants continue with or switch back to SROM for another 6 month (week 23 to 47).

Sevre-Long™

Slow release oral morphine DRUG

Sevre-Long™

Methadone DRUG

Methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age: 18 years
• Fixed abode
• At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or
• Mature and capable of acting responsibly, in possession of all mental faculties
• Female subjects must have a negative urine pregnancy test recorded prior to the first dose of study medication and regular negative urine pregnancy tests every 4 weeks. SUB9001 - Integrated Study Protocol 10/58 June 13, 2009
• Hormonal contraception (oral, transdermal, vaginal, intrauterine or subcutaneous) by women of child-bearing age
• No intention of reducing the substitute medication during the trial
• Acceptance of the trials rules and regulations
• Acceptance to participate in the study.

You may not qualify if:

• (Desired) pregnancy during the trial
• Breastfeeding women
• Grave or acute somatic illnesses (e.g. cardio-vascular, serious kidney or liver affection (ALAT or ASAT \> 5x augmented)) or other somatic disorder
• If suffering from severe unstable mental health problems
• If MAO-Inhibitors or are being taken
• Intracranial injury
• Intracranial hypertension
• History of epilepsy
• Severe chronic obstructive lung disease
• Chronic respiratory failure
• Known hypersensitivity to morphine or methadone
• Pancreatitis
• Paralytic ileus
• Baseline QTc interval greater than 450 msec
• Long QT Syndrome

Sponsors & Collaborators

• Mundipharma Medical Company: lead

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

Related Publications (3)

• Beck T, Haasen C, Verthein U, Walcher S, Schuler C, Backmund M, Ruckes C, Reimer J. Maintenance treatment for opioid dependence with slow-release oral morphine: a randomized cross-over, non-inferiority study versus methadone. Addiction. 2014 Apr;109(4):617-26. doi: 10.1111/add.12440. Epub 2014 Jan 19.

  PMID: 24304412 RESULT

• Falcato L, Beck T, Reimer J, Verthein U. Self-reported cravings for heroin and cocaine during maintenance treatment with slow-release oral morphine compared with methadone: a randomized, crossover clinical trial. J Clin Psychopharmacol. 2015 Apr;35(2):150-7. doi: 10.1097/JCP.0000000000000288.

  PMID: 25679130 DERIVED

• Hammig R, Kohler W, Bonorden-Kleij K, Weber B, Lebentrau K, Berthel T, Babic-Hohnjec L, Vollmert C, Hopner D, Gholami N, Verthein U, Haasen C, Reimer J, Ruckes C. Safety and tolerability of slow-release oral morphine versus methadone in the treatment of opioid dependence. J Subst Abuse Treat. 2014 Oct;47(4):275-81. doi: 10.1016/j.jsat.2014.05.012. Epub 2014 Jun 10.

  PMID: 25064422 DERIVED

Related Links

• Published study results

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

CH (1)