Opiate DependenceNAMEKONCT01160432
Naloxone Methadone Combination (NAMEKO)
A study testing Methadone, naloxone in people with Opiate Dependence, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Methadone, naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- May 2013to Jul 2013
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opioid dependence
- methadone treatment
- no changes in methadone dose during the last 10 days
- good treatment compliance according to doctor
- normal ALAT and AFOS values (increased if double the normal level)
Who cannot join
- severe renal or hepatic failure
- acute psychosis
- age under 18
- pregnancy
- legal incompetence
- severe somatic disease
- chaotic situation in life
- medication or disease which is contraindication to study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.
Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.
- Conditions
- Opiate Dependence
- Being tested
- Methadone, naloxone
- Keywords
- opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment
- Medical subject headings
- Opioid-Related Disorders, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone, naloxoneDrug
Also called Methadone Martindale Pharma
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml daily according to patient's individual dose. At first open label pilot using single (individual) dosage for 2 patients. After that crossover study using methadone 2 mg/ml in combination with naloxone 0,04 mg/ml compared to methadone 2 mg/ml alone in one week's periods for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Methadone naloxone combination product 2/0,04 mg/ml | Experimental | Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml Receives: Drug: Methadone, naloxone |
| Methadone 2 mg/ml | Active comparator | Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml). Receives: Drug: Methadone, naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).
Measured: 1/2 hours after the first intake of medicine every week
Secondary outcomes (1)
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
Measured: Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Tacke, Kuopio University Hospital
- Investigators
- Ulrich Tacke, MD, PhD, Study director, Kuopio University Hospital, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160432
- Sponsor's protocol ID
- KUH5703433
- Other IDs
- 2010-021814-43
- Acronym
- NAMEKO
- Status last verified
- Jul 2013
- First submitted
- 9 Jul 2010
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
- ClinicalTrials.gov ID
- NCT01160432
- Acronym / sponsor ID
- NAMEKO / KUH5703433
- Conditions
- Opiate Dependence
- Keywords
- opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 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.
The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.
Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone naloxone combination product 2/0,04 mg/ml | Experimental | Drug: Methadone, naloxoneMethadone 2 mg/ml in combination with naloxone 0,04 mg/ml |
| Methadone 2 mg/ml | Active comparator | Drug: Methadone, naloxoneNormal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- opioid dependence
- methadone treatment
- no changes in methadone dose during the last 10 days
- good treatment compliance according to doctor
- normal ALAT and AFOS values (increased if double the normal level)
Key exclusion criteria (8 listed)
- severe renal or hepatic failure
- acute psychosis
- age under 18
- pregnancy
- legal incompetence
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 |
|---|---|---|
| Methadone, naloxoneAlso: Methadone Martindale PharmaMethadone 2 mg/ml in combination with naloxone 0,04 mg/ml daily according to patient's individual dose. At first open label pilot using single (individual) dosage for 2 patients. After that crossover study using methadone 2 mg/ml in combination with naloxone 0,04 mg/ml compared to methadone 2 mg/ml alone in one week's periods for four weeks. | Drug | Methadone 2 mg/ml, Methadone naloxone combination product 2/0,04 mg/ml |
Primary outcome
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
Time frame: 1/2 hours after the first intake of medicine every week
COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).
1 secondary outcome
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Time frame: Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
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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.
Ulrich Tacke, MD, PhD study director
Kuopio University Hospital, University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methadone, naloxone in people with Opiate Dependence, run by Kuopio University Hospital at 1 site in Finland.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 Jul 2013. 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 Finland. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS) (time frame: 1/2 hours after the first intake of medicine every week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2013.