Treatment of Polydrug-Using Opiate Dependents During Withdrawal

NCT00367874 | Completed Phase 4

• 1 other identifier: SSHF_ARA_001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. Objectives

1. 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. 2.To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
3. 3.To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.

Conditions

Opiate Dependence; Drug Dependence; Substance Withdrawal Syndrome

Keywords

Opiate dependence; Benzodiazepine dependence; Polydrug Abuse; Detoxification; Withdrawal Treatment

Outcome Measures

Primary Outcomes (2)

• Retention in treatment

• Withdrawal symptoms

Secondary Outcomes (2)

• Serum concentration of Valproate and Buprenorphine separately and in combination

• Urine testing

Interventions

Buprenorphine DRUG

Valproate DRUG

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Polydrug dependency (at least opiate and benzodiazepine dependency)

You may not qualify if:

• No severe psychiatric illness
• No history of epilepsy seizures
• No pregnancy or breastfeeding
• Fertile women must use contraceptives

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital HF, Addiction Unit (ARA)

Kristiansand, Vest-Agder, N-4604, Norway

Location

Related Publications (1)

• 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. doi: 10.1186/1471-244X-6-54.

  PMID: 17107609 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome

Interventions

Buprenorphine; Valproic Acid

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Oistein Kristensen, MD

  Sorlandet Hospital HF, Addiction Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 23, 2006
• Study Start: February 1, 2003
• Study Completion: November 1, 2003
• Last Updated: August 23, 2006

Record last verified: 2006-08

Locations

NO (1)