Treatment of Polydrug-Using Opiate Dependents During With... | NCT00367874

Studies
Treatment of Polydrug-Using Opiate Dependents During Withdrawal

NCT00367874

Sponsor

Sorlandet Hospital HF

Status

Completed

Last Update Posted

Aug 23, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Opiate Dependence
Drug Dependence
Substance Withdrawal Syndrome

Interventions

Buprenorphine
Valproate

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Nov 2003

First Submitted Date

Aug 22, 2006

First Submission Date that Met QC Criteria

Aug 22, 2006

First Posted Date

Aug 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2006

Last Update Posted Date

Aug 23, 2006Estimated

Description Module

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

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention in treatment
Withdrawal symptoms

Secondary Outcomes

Measure	Description	Time Frame
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oistein Kristensen, MD	Sorlandet Hospital HF, Addiction Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sorlandet Hospital HF, Addiction Unit (ARA)		Kristiansand	Vest-Agder	N-4604	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17107609	Derived	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.

ID	Term
D009293	Opioid-Related Disorders
D019966	Substance-Related Disorders
D013375	Substance Withdrawal Syndrome

ID	Term
D000079524	Narcotic-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D002047	Buprenorphine
D014635	Valproic Acid

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug
Valproate	Drug