Treatment of Polydrug-Using Opiate Dependents During Withdrawal - Full Text View

Sponsor:	Sorlandet Hospital HF
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00367874

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

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).
To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

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

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367874

Locations

Norway, Vest-Agder
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

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kristensen O, Lolandsmo T, Isaksen A, Vederhus JK, Clausen T. Treatment of polydrug-using opiate dependents during withdrawal: towards a standardisation of treatment. BMC Psychiatry. 2006 Nov 15;6:54.

Study ID Numbers:	SSHF_ARA_001
Study First Received:	August 22, 2006
Last Updated:	August 22, 2006
ClinicalTrials.gov Identifier:	NCT00367874 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Sorlandet Hospital HF:

Opiate dependence
Benzodiazepine dependence
Polydrug Abuse
Detoxification
Withdrawal Treatment

Additional relevant MeSH terms:

Neurotransmitter Agents
Substance Withdrawal Syndrome
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Narcotic Antagonists
Psychotropic Drugs
Disorders of Environmental Origin
Opioid-Related Disorders
Valproic Acid
Buprenorphine
Pathologic Processes
Sensory System Agents
Mental Disorders
Syndrome
Therapeutic Uses

Substance-Related Disorders
Analgesics
Analgesics, Opioid
Disease
Tranquilizing Agents
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Antimanic Agents
Pharmacologic Actions
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010