Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Opiate Dependence Clinical Trial

Official title:

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367874
• Other study ID #: SSHF_ARA_001
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2006
• Last updated: August 22, 2006
• Start date: February 2003
• Est. completion date: November 2003

Study information

• Verified date: August 2006
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Dependence
• Opiate Dependence
• Opioid-Related Disorders
• Substance Withdrawal Syndrome

Intervention

Drug:
• Buprenorphine

• Valproate

Locations

Country	Name	City	State
Norway	Sorlandet Hospital HF, Addiction Unit (ARA)	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment
Primary	Withdrawal symptoms
Secondary	Serum concentration of Valproate and Buprenorphine separately and in combination
Secondary	Urine testing