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OpenTrials
Completed

NCT Number: NCT00367874

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

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.

Completed

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Drug Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sorlandet Hospital HF, Addiction Unit (ARA)

Kristiansand, Vest-Agder, N-4604, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Valproate

Drug

Primary outcomes

  1. Retention in treatment

  2. Withdrawal symptoms

Secondary outcomes

  1. Serum concentration of Valproate and Buprenorphine separately and in combination

  2. Urine testing

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Important dates

Study start
2003
Study completion
2003
First posted
Aug 23, 2006
Registry last updated
Aug 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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