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Treatment of Polydrug-Using Opiate Dependents During Withdrawal

NCT00367874 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2006-08-23

No results posted yet for this study

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

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.

Conditions

  • Opiate Dependence
  • Drug Dependence
  • Substance Withdrawal Syndrome

Interventions

DRUG

Buprenorphine

DRUG

Valproate

Sponsors & Collaborators

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Oistein Kristensen, MD · Sorlandet Hospital HF, Addiction Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2003-11-30

Countries

  • Norway

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367874 on ClinicalTrials.gov