Opiate DependentPhase 3NCT01079117
Morphine Slow-release Capsules in Substitution Therapy
A Phase 3 study testing Sevre-Long™, Slow release oral morphine and Methadone in people with Opiate Dependent, run by Mundipharma Medical Company at 1 site in Switzerland.
Trial summary
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependent
- What is being tested?
- Sevre-Long™, Slow release oral morphine and Methadone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2006to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age: 18 years
- Fixed abode
- At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or
- ≥ 25 mg/day levomethadone at inclusion. Patients on levomethadone must be informed and agree to be switched to methadone
- 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
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- 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.
Who cannot join
- (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
Show all 17Show fewer
- 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
- Patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry
- Patients with pending imprisonment at the time of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone
Read the detailed description
The objective of this study is to compare the effectiveness of slow-release oral morphine (SROM) treatment in patients that previously have been treated with methadone. Efficacy is assessed by the frequency of by-consumption of illicit substances. 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.
The secondary endpoints are:
- The effects of SROM on retention rate.
- By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines).
- Occurring psychopathological and somatic symptoms.
- Effect of treatment on the ECG (QTc prolongation).
- Group characterisation of patients that is keen to change the medication.
- The change in dosage of treatment over time.
- Self-assessed craving for Opioids.
- Self-assessed satisfaction with treatment.
- Nature, frequency and severity of occurring adverse events in the two treatment groups.
- Assessment of safety parameters.
Study Design (Methodology):
This is a multicentre, multinational phase III study. It is conducted using a randomised, open label cross-over design. 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 SUB9001 - Integrated Study Protocol 9/58 June 13, 2009 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).
- Conditions
- Opiate Dependent
- Being tested
- Sevre-Long™, Slow release oral morphine, Methadone
- Keywords
- Opiate, Methadone, Slow Release Oral Morphine (SORM), Sevre-Long™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Slow release oral morphineDrug
MethadoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevre-Long™ | Active comparator | slow release oral morphine Receives: Drug: Sevre-Long™; Drug: Slow release oral morphine |
| Methadone | Active comparator | Methodone Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: each week during the 22 week cross-over phase
Secondary outcomes (10)
Secondary Outcome Measures
The effects of SROM on retention rate
Measured: throughout the 22 week cross over period
By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines)
Measured: throughout the 22 week cross over period
Occurring psychopathological and somatic symptoms.
Measured: througout the 22 week cross over period
Effect of treatment on the ECG (QTc prolongation)
Measured: throughout the 22 week cross over phase
Group characterisation of patients that is keen to change the medication
Measured: throughout the 22 week cross over period
The change in dosage of treatment over time
Measured: throughout the 22 week cross over period
Self-assessed craving for Opioids
Measured: throughout the 22 week cross over period
Self-assessed satisfaction with treatment.
Measured: throughout the 22 week cross over period
Nature, frequency and severity of occurring adverse events in the two treatment groups
Measured: throughout the 22 week cross over period
Assessment of safety parameters
Measured: throughout the 22 week cross over period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startOct 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opiate DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079117
- Sponsor's protocol ID
- SUB9001
- Other IDs
- 2008-002185-60, 2008
- Status last verified
- Mar 2014
- First submitted
- 1 Mar 2010
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24304412Falcato 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.
PubMed 25679130Hammig 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.
PubMed 25064422
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)
- ClinicalTrials.gov ID
- NCT01079117
- Acronym / sponsor ID
- SUB9001
- Conditions
- Opiate Dependent
- Keywords
- Opiate, Methadone, Slow Release Oral Morphine (SORM), Sevre-Long™
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Mundipharma Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone
Detailed description
The objective of this study is to compare the effectiveness of slow-release oral morphine (SROM) treatment in patients that previously have been treated with methadone. Efficacy is assessed by the frequency of by-consumption of illicit substances. 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.
The secondary endpoints are:
- The effects of SROM on retention rate.
- By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines).
- Occurring psychopathological and somatic symptoms.
- Effect of treatment on the ECG (QTc prolongation).
- Group characterisation of patients that is keen to change the medication.
- The change in dosage of treatment over time.
- Self-assessed craving for Opioids.
- Self-assessed satisfaction with treatment.
- Nature, frequency and severity of occurring adverse events in the two treatment groups.
- Assessment of safety parameters.
Study Design (Methodology):
This is a multicentre, multinational phase III study. It is conducted using a randomised, open label cross-over design. 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 SUB9001 - Integrated Study Protocol 9/58 June 13, 2009 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevre-Long™ | Active comparator | Drug: Sevre-Long™, Drug: Slow release oral morphineslow release oral morphine |
| Methadone | Active comparator | Drug: MethadoneMethodone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum age: 18 years
- Fixed abode
- At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or
- ≥ 25 mg/day levomethadone at inclusion. Patients on levomethadone must be informed and agree to be switched to methadone
- Mature and capable of acting responsibly, in possession of all mental faculties
Key exclusion criteria (17 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevre-Long™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). | Drug | Sevre-Long™ |
| Slow release oral morphine | Drug | Sevre-Long™ |
| Methadone | Drug | Methadone |
Primary outcome
Proportion of positive urine tests for by-consumption of target substances per subject
Time frame: each week during the 22 week cross-over phase
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.
10 secondary outcomes
Secondary Outcome Measures
Time frame: throughout the 22 week cross over period
By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines)
Time frame: throughout the 22 week cross over period
Occurring psychopathological and somatic symptoms.
Time frame: througout the 22 week cross over period
Effect of treatment on the ECG (QTc prolongation)
Time frame: throughout the 22 week cross over phase
Group characterisation of patients that is keen to change the medication
Time frame: throughout the 22 week cross over period
The change in dosage of treatment over time
Time frame: throughout the 22 week cross over period
Self-assessed craving for Opioids
Time frame: throughout the 22 week cross over period
Self-assessed satisfaction with treatment.
Time frame: throughout the 22 week cross over period
Nature, frequency and severity of occurring adverse events in the two treatment groups
Time frame: throughout the 22 week cross over period
Assessment of safety parameters
Time frame: throughout the 22 week cross over period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Results publication: PubMed 24304412Beck 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.
- Derived from this study: PubMed 25679130Falcato 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.
- Derived from this study: PubMed 25064422Hammig 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.
- Published study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevre-Long™, Slow release oral morphine and Methadone in people with Opiate Dependent, run by Mundipharma Medical Company at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of positive urine tests for by-consumption of target substances per subject (time frame: each week during the 22 week cross-over phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.