Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Opiate Dependence Drug Dependence Substance Withdrawal Syndrome

Keywords

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Opiate dependence Benzodiazepine dependence Polydrug Abuse Detoxification Withdrawal Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Buprenorphine

Intervention Type DRUG

Valproate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Oistein Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Sorlandet Hospital HF, Addiction Unit

Locations

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Sorlandet Hospital HF, Addiction Unit (ARA)

Kristiansand, Vest-Agder, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED

PMID: 17107609 (View on PubMed)

Other Identifiers

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SSHF_ARA_001

Identifier Type: -

Identifier Source: org_study_id