Heroin AddictionPhase 4NCT00750217
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches
A Phase 4 study testing Buprenorphine patch and sublingual tablets in people with Heroin Addiction, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Heroin Addiction
- What is being tested?
- Buprenorphine patch and sublingual tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to May 2009
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Methadone maintenance treatment for at least 3 months preceding the study
- Daily methadone dosage between 60mg amd 100mg
- Sufficient knowledge of German language
- Ability to give informed consent
Who cannot join
- Daily methadone dosage below 60mg amd over 100mg
- Prescribed use of benzodiazepines over 30 mg equivalent to diazepam
- Misuse or dependence of alcohol and/or GHB/GBL
- Pregnant or breast-feeding women
- Known intolerance of buprenorphine
- Somatic diseases interfering with the study plan
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospital
Zurich, Canton of Zurich, 8032
Melanie Hess, med. pract., 0041 44 384 21 11, melanie.hess@puk.zh.ch
Rudolf Stohler, MD, 0041 44 205 58 00, rudolf.stohler@puk.zh.ch
About this study
Official title: Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone.
Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.
- Conditions
- Heroin Addiction
- Being tested
- Buprenorphine patch and sublingual tablets
- Keywords
- transfer methadone buprenorphine patch heroin addiction
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine patch and sublingual tabletsDrug
Also called Transtec (buprenorphine patch), Subutex (buprenorphine sublingual tablets)
Buprenorphine patch: 35 micro grams per hour 12 to 48 hours after last methadone intake.
Buprenorphine sublingual tablets: 2mg 48 and 60 hours after last methadone intake; 8mg 72 and 84 hours after last methadone intake; 8mg 96, 102 and 109 hours after last methadone intake.
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Opiate Withdrawal Scale
Measured: 14 days
Secondary outcomes (1)
Heroin use
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AddictionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Rudolf Stohler, MD, Study director, Psychiatric University HospitalLukas Boesch, PhD, Study chair, Psychiatirc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750217
- Sponsor's protocol ID
- E-54/2007
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2008
- Last updated
- 10 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone.
- ClinicalTrials.gov ID
- NCT00750217
- Acronym / sponsor ID
- E-54/2007
- Conditions
- Heroin Addiction
- Keywords
- transfer methadone buprenorphine patch heroin addiction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 10 Sep 2008 (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.
Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years
- Methadone maintenance treatment for at least 3 months preceding the study
- Daily methadone dosage between 60mg amd 100mg
- Sufficient knowledge of German language
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Daily methadone dosage below 60mg amd over 100mg
- Prescribed use of benzodiazepines over 30 mg equivalent to diazepam
- Misuse or dependence of alcohol and/or GHB/GBL
- Pregnant or breast-feeding women
- Known intolerance of buprenorphine
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 |
|---|---|---|
| Buprenorphine patch and sublingual tabletsAlso: Transtec (buprenorphine patch), Subutex (buprenorphine sublingual tablets)Buprenorphine patch: 35 micro grams per hour 12 to 48 hours after last methadone intake. Buprenorphine sublingual tablets: 2mg 48 and 60 hours after last methadone intake; 8mg 72 and 84 hours after last methadone intake; 8mg 96, 102 and 109 hours after last methadone intake. | Drug | – |
Primary outcome
Short Opiate Withdrawal Scale
Time frame: 14 days
1 secondary outcome
Heroin use
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2008.
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Enrolling by invitation
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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.
Rudolf Stohler, MD study director
Psychiatric University Hospital
Lukas Boesch, PhD study chair
Psychiatirc University Hospital
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 Buprenorphine patch and sublingual tablets in people with Heroin Addiction, run by Psychiatric University Hospital, Zurich 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Sep 2008. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Opiate Withdrawal Scale (time frame: 14 days). 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 10 Sep 2008.