Back to resultsTreatment of Polydrug-Using Opiate Dependents During Withdrawal
Primary Purpose
Opiate Dependence, Drug Dependence, Substance Withdrawal Syndrome
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Buprenorphine
Valproate
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring Opiate dependence, Benzodiazepine dependence, Polydrug Abuse, Detoxification, Withdrawal Treatment
Eligibility Criteria
Inclusion Criteria: - Polydrug dependency (at least opiate and benzodiazepine dependency) Exclusion Criteria: No severe psychiatric illness No history of epilepsy seizures No pregnancy or breastfeeding Fertile women must use contraceptives
Sites / Locations
- Sorlandet Hospital HF, Addiction Unit (ARA)
Outcomes
Primary Outcome Measures
Retention in treatment
Withdrawal symptoms
Secondary Outcome Measures
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367874
Brief Title
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Official Title
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, Drug Dependence, Substance Withdrawal Syndrome
Keywords
Opiate dependence, Benzodiazepine dependence, Polydrug Abuse, Detoxification, Withdrawal Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Type
Drug
Intervention Name(s)
Valproate
Primary Outcome Measure Information:
Title
Retention in treatment
Title
Withdrawal symptoms
Secondary Outcome Measure Information:
Title
Serum concentration of Valproate and Buprenorphine separately and in combination
Title
Urine testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Polydrug dependency (at least opiate and benzodiazepine dependency)
Exclusion Criteria:
No severe psychiatric illness
No history of epilepsy seizures
No pregnancy or breastfeeding
Fertile women must use contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oistein Kristensen, MD
Organizational Affiliation
Sorlandet Hospital HF, Addiction Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital HF, Addiction Unit (ARA)
City
Kristiansand
State/Province
Vest-Agder
ZIP/Postal Code
N-4604
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
17107609
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
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