Opiate DependencePhase 4NCT00367874
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
A Phase 4 study testing Buprenorphine and Valproate in people with Opiate Dependence and Drug Dependence, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Opiate Dependence, Drug Dependence, Substance Withdrawal Syndrome
- What is being tested?
- Buprenorphine and Valproate
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2003to Nov 2003
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Polydrug dependency (at least opiate and benzodiazepine dependency)
Who cannot join
- No severe psychiatric illness
- No history of epilepsy seizures
- No pregnancy or breastfeeding
- Fertile women must use contraceptives
Trial locations and contacts
1 site in 1 country.
Norway1 site
Sorlandet Hospital HF, Addiction Unit (ARA)
Kristiansand, Vest-Agder, N-4604
About this study
Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment.
In our clinical practice we have felt the need for a standardised and safe detoxification treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.
Read more
Objectives
- To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined with Carbamazepine (CBZ).
- To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
- To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.
- Being tested
- Buprenorphine, Valproate
- Keywords
- Opiate dependence, Benzodiazepine dependence, Polydrug Abuse, Detoxification, Withdrawal Treatment
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
ValproateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Withdrawal symptoms
Secondary outcomes (2)
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startFeb 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Investigators
- Oistein Kristensen, MD, Principal investigator, Sorlandet Hospital HF, Addiction Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367874
- Sponsor's protocol ID
- SSHF_ARA_001
- Status last verified
- Aug 2006
- First submitted
- 22 Aug 2006
- Last updated
- 23 Aug 2006
- Results posted
- No
Publications
Kristensen O, Lolandsmo T, Isaksen A, Vederhus JK, Clausen T. Treatment of polydrug-using opiate dependents during withdrawal: towards a standardisation of treatment. BMC Psychiatry. 2006 Nov 15;6:54. doi: 10.1186/1471-244X-6-54.
PubMed 17107609
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Polydrug-Using Opiate Dependents During Withdrawal
- ClinicalTrials.gov ID
- NCT00367874
- Acronym / sponsor ID
- SSHF_ARA_001
- Keywords
- Opiate dependence, Benzodiazepine dependence, Polydrug Abuse, Detoxification, Withdrawal Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Feb 2003
- Study completion
- Nov 2003
- First posted
- 23 Aug 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.
Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment.
In our clinical practice we have felt the need for a standardised and safe detoxification treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.
Objectives
- To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined with Carbamazepine (CBZ).
- To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
- To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polydrug dependency (at least opiate and benzodiazepine dependency)
Key exclusion criteria (4 listed)
- No severe psychiatric illness
- No history of epilepsy seizures
- No pregnancy or breastfeeding
- Fertile women must use contraceptives
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 | Drug | – |
| Valproate | Drug | – |
Primary outcome
Retention in treatment
Withdrawal symptoms
2 secondary outcomes
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing
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 23 Aug 2006.
- Derived from this study: PubMed 17107609Kristensen O, Lolandsmo T, Isaksen A, Vederhus JK, Clausen T. Treatment of polydrug-using opiate dependents during withdrawal: towards a standardisation of treatment. BMC Psychiatry. 2006 Nov 15;6:54. doi: 10.1186/1471-244X-6-54.
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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.
Oistein Kristensen, MD principal investigator
Sorlandet Hospital HF, Addiction Unit
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 and Valproate in people with Opiate Dependence and Drug Dependence, run by Sorlandet Hospital HF at 1 site in Norway.
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 1 inclusion and 4 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 23 Aug 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 Norway. 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. The study lists 2 primary outcomes in all. 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 NCT00367874, which also lists 1 linked publication.
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 23 Aug 2006.