Opioid dependence, ICD classification code F11.2 (ICD-10)
Conditions
Interventions
Trade Name: Diaphin 10gm ampoules
Product Name: Diaphin
Product Code: N/A
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: diamorphine hydrochloride
CAS Number:
-10mg in 1ml
Trade Name: methadone DFT
Pharmaceutical Form: Oral solution
INN or Proposed INN: methadone hydrochloride BP
CAS Number: 1095-90-5
Other descriptive name: oral methadone
Concentration u
Sponsors
Kings College London/South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged between 18-65 years at recruitment to study 2. at least 3-year history of injecting heroin use sufficient to meet DSM-IVR criteria 3. in continuous methadone treatment for at least 6 months this episode 4. regular injecting heroin use in preceding 3 months as evidenced by opiate -positive urine drug screens and patient self-report in clinical notes, use of heroin on at least 50% of days in the preceding month on self-report (>14 days in past 4 weeks), and evidence of regular injecting on clinical examination. 5. able and willing to participate in the study procedures (eg. no impending prison sentence ) and provide informed consent. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. no active significant medical (eg. severe hepatic dysfunction) or psychiatric condition (psychosis, severe affective state), as determined by study medical officer. 2. not alcohol dependent or abusing benezodiazepines according to DSM-1VR criteria. 3. Not pregnant, breatfeeding, or planning to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the safety, efficacy and cost effectiveness of treatment with optimised oral methadone treatment compared to injectable methadone or injectable heroin, for patients not responding to their current oral maintenance treatment episode, on the following outcomes: 1. illicit heroin and other drug use 2. high risk injecting practices 3. indices of general health and psychosocial functioning 4. criminal activity 5. treatment retention 6. cost-effectiveness in enhancing quality of life indices and reducing illicit heroin use;Secondary Objective: 1. what proportion of patients in existing methadone programs are preforming poorly in conventional treatment 2. what proportion of these patients are interested in commencing injectable opioid treatment; and 3. patient satisfaction measures with each of the three treatment approaches, exploring patient perspectives of the relative advantages and disadvantages of each approach. ;Primary end point(s): treatment retention proportion of patients who continue to use illicit heroin on a regular basis (at least 50% of days in preceding month) | — |
Countries
United Kingdom
Outcome results
None listed