MedPath

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Phase 4
Completed
Conditions
Opiate Dependence
Drug Dependence
Substance Withdrawal Syndrome
Registration Number
NCT00367874
Lead Sponsor
Sorlandet Hospital HF
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

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Retention in treatment
Withdrawal symptoms
Secondary Outcome Measures
NameTimeMethod
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing

Trial Locations

Locations (1)

Sorlandet Hospital HF, Addiction Unit (ARA)

🇳🇴

Kristiansand, Vest-Agder, Norway

© Copyright 2025. All Rights Reserved by MedPath