Treatment of Polydrug-Using Opiate Dependents During Withdrawal

August 22, 2006 updated by: Sorlandet Hospital HF

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

  1. 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).
  2. To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
  3. To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vest-Agder
      • Kristiansand, Vest-Agder, Norway, N-4604
        • Sorlandet Hospital HF, Addiction Unit (ARA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Withdrawal symptoms
Retention in treatment

Secondary Outcome Measures

Outcome Measure
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Oistein Kristensen, MD, Sorlandet Hospital HF, Addiction Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

November 1, 2003

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Estimate)

August 23, 2006

Last Update Submitted That Met QC Criteria

August 22, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSHF_ARA_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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