Benzodiazepine dependence
Conditions
Interventions
Trade Name: Sobril
Product Name: oxazepam
Pharmaceutical Form: Tablet
Trade Name: Sobril
Product Name: oxazepam
Pharmaceutical Form: Tablet
Trade Name: Valium, Vival, Stesolid
Product Name: diazepam
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult age (= 18 years) • Opioid dependence according to ICD-10, and ongoing OAT • Benzodiazepine dependence according to ICD-10 under the following conditions: - Minimum duration is the last 5 years - Use 5-7 days a week during the last month - Minimum dose used is equivalent to 15 mg diazepam/d or higher Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe respiratory failure (GOLD 3-4) • High risk of violent behavior (current violence episodes) • High risk of substance related overdose (current overdoses) • Severe cognitive impairment (IQ<70) • Severe psychosis (current psychotic symptoms and functioning) • Severe depression and high suicide risk (current episodes) • Patients who are already being prescribed continuous benzodiazepines • Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess impact on use of illicit benzodiazepines of maintenance treatment with prescribed benzodiazepines compared with the standard interventions i.e. gradual tapering and psychosocial approaches in patients with concurrent benzodiazepine and opioid dependence undergoing OAT;Secondary Objective: To compare between the intervention and standard arm: ? Changes in mental health symptoms ? Changes in cognitive functioning ? Changes in health-related quality of life Further, to compare between the two arms: ? Treatment satisfaction ? Retention rate in OAT ? Use of other illicit substances and alcohol ? Violent behavior ? Changes in non-fatal overdose and death (if sufficient numbers);Primary end point(s): The difference between the two study arms with regard to reduction in illicit benzodiazepine use at the end of study period.;Timepoint(s) of evaluation of this end point: week 24 and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The difference between the two study arms with regard to ? Changes in mental health symptoms ? Changes in cognitive functioning ? Changes in health-related quality of life ? Treatment satisfaction ? Retention rate in OAT ? Use of other illicit substances and alcohol ? Violent behavior ? Changes in non-fatal overdose and death (if sufficient numbers);Timepoint(s) of evaluation of this end point: week 24 and week 52 | — |
Countries
Norway
Contacts
Public ContactAvd for rusmedisin
Helse Bergen HF
Outcome results
None listed