Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Information source: Sorlandet Hospital HF
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence; Drug Dependence; Substance Withdrawal Syndrome
Intervention: Buprenorphine (Drug); Valproate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sorlandet Hospital HF Official(s) and/or principal investigator(s):
Oistein Kristensen, MD, Principal Investigator, Affiliation: Sorlandet Hospital HF, Addiction Unit
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.
Clinical Details
Official title: Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Retention in treatmentWithdrawal symptoms
Secondary outcome: Serum concentration of Valproate and Buprenorphine separately and in combinationUrine testing
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Sorlandet Hospital HF, Addiction Unit (ARA), Kristiansand, Vest-Agder N-4604, Norway
Additional Information
Starting date: February 2003
Ending date: November 2003
Last updated: August 22, 2006
|
