Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.
Trial record 15 of 40 for:    CARBAMAZEPINE AND Valproic Acid

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

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. Identifier: NCT00367874
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : August 23, 2006
Information provided by:
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.


  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 or disease Intervention/treatment Phase
Opiate Dependence Drug Dependence Substance Withdrawal Syndrome Drug: Buprenorphine Drug: Valproate Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
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
Study Start Date : February 2003
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Retention in treatment
  2. Withdrawal symptoms

Secondary Outcome Measures :
  1. Serum concentration of Valproate and Buprenorphine separately and in combination
  2. Urine testing

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT00367874

Layout table for location information
Sorlandet Hospital HF, Addiction Unit (ARA)
Kristiansand, Vest-Agder, Norway, N-4604
Sponsors and Collaborators
Sorlandet Hospital HF
Layout table for investigator information
Principal Investigator: Oistein Kristensen, MD Sorlandet Hospital HF, Addiction Unit

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00367874    
Other Study ID Numbers: SSHF_ARA_001
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: August 23, 2006
Last Verified: August 2006
Keywords provided by Sorlandet Hospital HF:
Opiate dependence
Benzodiazepine dependence
Polydrug Abuse
Withdrawal Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Valproic Acid
Opioid-Related Disorders
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
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