The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Helsinki
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- benzodiazepine withdrawal severity
Study Overview
Brief Summary
The aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.
Detailed Description
In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths.
Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of benzodiazepine dependence (DSM IV-R)
- •Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance
Exclusion Criteria
- •Pregnancy
- •History of convulsions
- •Unstable somatic diseases
Arms & Interventions
B
Gradual benzodiazepine discontinuation and valproate treatment
Intervention: valproate (Drug)
Outcomes
Primary Outcomes
benzodiazepine withdrawal severity
Time Frame: 3 weeks
Secondary Outcomes
- attrition from treatment(3 weeks)
- benzodiazepine use(4 weeks after treatment)