Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Sorlandet Hospital HF

Status and phase: Completed; Phase 4

Conditions: Drug Dependence; Opiate Dependence; Substance Withdrawal Syndrome

Treatments: Drug: Valproate; Drug: Buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00367874

SSHF_ARA_001

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)