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Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Treatment of Polydrug-Using Opiate Dependents During Withdrawal

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00367874
Enrollment
12
Registered
2006-08-23
Start date
2003-02-28
Completion date
2003-11-30
Last updated
2006-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Dependence, Opiate Dependence, Substance Withdrawal Syndrome

Keywords

Opiate dependence, Benzodiazepine dependence, Polydrug Abuse, Detoxification, Withdrawal Treatment

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.

Interventions

DRUGBuprenorphine
DRUGValproate

Sponsors

Sorlandet Hospital HF
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Retention in treatment
Withdrawal symptoms

Secondary

MeasureTime frame
Serum concentration of Valproate and Buprenorphine separately and in combination
Urine testing

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026