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CompletedNCT00367874Updated Aug 23, 2006

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

A Phase 4 interventional study of Buprenorphine and Valproate in Opiate Dependence, Drug Dependence and Substance Withdrawal Syndrome, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2006-08-23.

Sponsored by Sorlandet Hospital HF · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Opiate Dependence
  • Drug Dependence
  • Substance Withdrawal Syndrome

Keywords

  • Opiate dependence
  • Benzodiazepine dependence
  • Polydrug Abuse
  • Detoxification
  • Withdrawal Treatment
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 12 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Sorlandet Hospital HF is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Polydrug dependency (at least opiate and benzodiazepine dependency)

Exclusion criteria

Exclusion Criteria:

  • No severe psychiatric illness
  • No history of epilepsy seizures
  • No pregnancy or breastfeeding
  • Fertile women must use contraceptives
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants

Interventions

  • DrugBuprenorphine
  • DrugValproate
06

What researchers measure

Primary outcomes

  1. Retention in treatment

  2. Withdrawal symptoms

Secondary outcomes

  1. Serum concentration of Valproate and Buprenorphine separately and in combination

  2. Urine testing

07

Study locations

1 site
  • Sorlandet Hospital HF, Addiction Unit (ARA)
    Kristiansand, Vest-Agder N-4604, Norway
08

References and documents

Publications

  • 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. PubMed 17107609 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00367874
Lead sponsor
Sorlandet Hospital HF
First posted
Aug 23, 2006
Start date
Feb 2003
Completion
Nov 2003
Last update
Aug 23, 2006

Study contacts

Oistein Kristensen, MD
principal investigator · Sorlandet Hospital HF, Addiction Unit
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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