This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

This study has been completed.
Information provided by:
Sorlandet Hospital HF Identifier:
First received: August 22, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

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.


  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

Resource links provided by NLM:

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

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00367874

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00367874     History of Changes
Other Study ID Numbers: SSHF_ARA_001
Study First Received: August 22, 2006
Last Updated: August 22, 2006

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Valproic Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Psychotropic Drugs processed this record on September 20, 2017