Heroin DependencePhase 4NCT00310934
A Stepwise Strategy Utilizing Buprenorphine and Methadone
A Phase 4 study testing methadone, buprenorphine / methadone sequence and Relapse prevention in people with Heroin Dependence, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- methadone, buprenorphine / methadone sequence and Relapse prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2005to Mar 2006
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heroin dependence according to DSM IV > 1year
- Age > 20 years
- Acceptance of the stated treatment principles.
Who cannot join
- Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
- Other clinically significant psychiatric illness unless stable under treatment
- Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
- Other clinically significant medical condition unless stable under treatment
- Treatment with anti-seizure drugs or disulfiram
- Pregnancy or intent to become pregnant within the next year
- Ongoing nursing
- Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Graded Strategy for Pharmacological Treatment of Heroin Dependence
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
Read the detailed description
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.
- Conditions
- Heroin Dependence
- Being tested
- methadone, buprenorphine / methadone sequence, Relapse prevention, Contingency management
- Keywords
- heroin dependence, methadone, buprenorphine, contingency management, relapse prevention
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methadoneDrug
buprenorphine / methadone sequenceDrug
Relapse preventionBehavioural
Contingency managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Secondary outcomes (2)
Proportion urine samples free of illicit drugs
Problem severity as measured by Addiction Severity Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startAug 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish National Drug Policy Coordinator, Region Stockholm, Schering-Plough
- Investigators
- Markus Heilig, MD PhD, Principal investigator, Karolinska Institute, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310934
- Sponsor's protocol ID
- KarolinskaUH Regional 373/03
- Status last verified
- Mar 2006
- First submitted
- 3 Apr 2006
- Last updated
- 24 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graded Strategy for Pharmacological Treatment of Heroin Dependence
- ClinicalTrials.gov ID
- NCT00310934
- Acronym / sponsor ID
- KarolinskaUH Regional 373/03
- Conditions
- Heroin Dependence
- Keywords
- heroin dependence, methadone, buprenorphine, contingency management, relapse prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Swedish National Drug Policy Coordinator, Region Stockholm, Schering-Plough
- Study start
- Aug 2005
- Study completion
- Mar 2006
- First posted
- 5 Apr 2006 (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 objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
Detailed description
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heroin dependence according to DSM IV > 1year
- Age > 20 years
- Acceptance of the stated treatment principles.
Key exclusion criteria (8 listed)
- Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
- Other clinically significant psychiatric illness unless stable under treatment
- Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
- Other clinically significant medical condition unless stable under treatment
- Treatment with anti-seizure drugs or disulfiram
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 | Drug | – |
| buprenorphine / methadone sequence | Drug | – |
| Relapse prevention | Behavioural | – |
| Contingency management | Behavioural | – |
Primary outcome
Retention in treatment
2 secondary outcomes
Proportion urine samples free of illicit drugs
Problem severity as measured by Addiction Severity Index
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 24 Oct 2006.
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.
Markus Heilig, MD PhD principal investigator
Karolinska Institute, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methadone, buprenorphine / methadone sequence and Relapse prevention in people with Heroin Dependence, run by Karolinska University Hospital at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 24 Oct 2006. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Retention in treatment. 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 24 Oct 2006.