Treatment of Polydrug-Using Opiate Dependents During Withdrawal

• Sponsor: Sorlandet Hospital HF (Other)
• Overall Status: Completed
• CT.gov ID: NCT00367874
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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. 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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2003
• Study Completion Date: Nov 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00367874
• Other Study ID Numbers: SSHF_ARA_001
• First Posted: Aug 23, 2006
• Last Update Posted: Aug 23, 2006
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: Opiate dependence; Benzodiazepine dependence; Polydrug Abuse; Detoxification; Withdrawal Treatment
• Additional relevant MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome; Substance-Related Disorders; Buprenorphine; Valproic Acid

Study Results

No Results Posted as of Aug 23, 2006