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

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 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Resource links provided by NLM:

Drug Information available for: Valproic acid Valproate sodium Buprenorphine Buprenorphine hydrochloride Divalproex 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
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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Sorlandet Hospital HF:

Opiate dependence
Benzodiazepine dependence
Polydrug Abuse
Detoxification
Withdrawal Treatment

Additional relevant MeSH terms:

Substance-Related Disorders
Substance Withdrawal Syndrome
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Valproic Acid
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013