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Treatment of Polydrug-Using Opiate Dependents During Withdrawal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367874
First Posted: August 23, 2006
Last Update Posted: August 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sorlandet Hospital HF
  Purpose

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.

Condition Intervention Phase
Opiate Dependence Drug Dependence Substance Withdrawal Syndrome Drug: Buprenorphine Drug: Valproate Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Retention in treatment
  • Withdrawal symptoms

Secondary Outcome Measures:
  • Serum concentration of Valproate and Buprenorphine separately and in combination
  • Urine testing

Estimated Enrollment: 12
Study Start Date: February 2003
Estimated Study Completion Date: November 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367874


Locations
Norway
Sorlandet Hospital HF, Addiction Unit (ARA)
Kristiansand, Vest-Agder, Norway, N-4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Oistein Kristensen, MD Sorlandet Hospital HF, Addiction Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00367874     History of Changes
Other Study ID Numbers: SSHF_ARA_001
First Submitted: August 22, 2006
First Posted: August 23, 2006
Last Update Posted: August 23, 2006
Last Verified: August 2006

Keywords provided by Sorlandet Hospital HF:
Opiate dependence
Benzodiazepine dependence
Polydrug Abuse
Detoxification
Withdrawal Treatment

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Opiate Alkaloids
Valproic Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Psychotropic Drugs